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market statistics.
EUROPEAN IVD MARKET STATISTICS REPORT 2020 European IVD Market Statistics Report 2020. MedTech Europe publishes every year the market estimates of the In Vitro Diagnostic industry in Europe. The 2020 edition is based on market size figures of 2019 and also includes macroeconomic and healthcare expenditure data for the EU 27 Member States, UK, as well as for the European Free TradeETHICAL MEDTECH
Medtech Europe. p.rojas@medtecheurope.org. +32 2 775 92 31. Pablo is a Legal & Compliance Manager at MedTech Europe, working on all topics in the Legal & Compliance team, with a focus on the implementation of the MedTech Europe Code of Ethical Business Practice. Pablo’s goal is to provide MedTech Europe members with support on any legal topic MEDTECH EUROPE GUIDANCE FOR ASSIGNING BASIC UDI-DI www.medtecheurope.org Page 1 of 18 GUIDANCE DOCUMENT MedTech Europe guidance for assigning Basic UDI-DI 2 June 2020 v1.1 Aim of the document The MedTech Europe Basic UDI-DI guidance document aims to provide a framework for companies to help FUTURE OF DIABETES CARE t.valentin@medtecheurope.org. Tanja Valentin. Director General. Medtech Europe. t.valentin@medtecheurope.org. +32 2 775 92 36. Tanja leads the External Affairs team at Medtech Europe. She is responsible for both internal and external Communication as well as for the organisation’s Government Affairs & Public Policy work. NEW IVD SYMBOLS FOR COMPLIANCE WITH THE IVDR By 26 May 2022, IVD devices will transition to the new IVD Regulation EU 2017/746. This regulation will require devices intended for self-testing, devices intended for near-patient testing and certain rapid tests (not for self-testing and not for near patient testing) to state these facts on their labels. The use of symbols on the label isan
TO THE EUROPEAN COMMISSION www.medtecheurope.org Page 1 of 2 Brussels, 07 May 2021 To the European Commission Executive Vice-President Dombrovskis and Commissioner Kyriakides Open Letter Re: Call to action to ensure continued supply of medical technologies between the EU and DETERMINING THE PATH FOR ASSESSMENT OF A COMPANION Determining the Path for Assessment of a Companion Diagnostic (CDx) under the In Vitro Diagnostic Medical Devices Regulation Introduction In May 2017, the Regulations on in vitro diagnostic medical devices entered into force in Europe: Regulation 2017/746 on in vitro diagnostic medical devices (IVDR). REVISED MANUFACTURER INCIDENT REPORTING FORM AND NEW The European Commission has published on its website the updated Manufacturer Incident Report (MIR) package which consists of the following documents: • New manufacturer incident report (v7.2 PDF form) • New manufacturer incident report for importing XML file with Adobe Professional • New manufacturer incident report XSD files (for implementation in manufacturer’ databases) • New MEDTECH EUROPE, FROM DIAGNOSIS TO CURE MedTech Europe is the European trade association representing the medical technology industries, from diagnosis to cure. We represent Diagnostics and Medical Devices manufacturers operating in Europe. There are more than 500,000 products, services and solutions currently made available by the medical technology industry. GLOBAL INVITRO DIAGNOSTIC (GIVD) CLASSIFICATION Global InVitro Diagnostic (GIVD) Classification – Version 2021. MedTech Europe has created a specific classification scheme for IVDs, the Global IVD (GIVD) classification (previously known as EDMA classification). It is a numerical coding system, which has been developed for the purpose to support the collection and analysis ofmarket statistics.
EUROPEAN IVD MARKET STATISTICS REPORT 2020 European IVD Market Statistics Report 2020. MedTech Europe publishes every year the market estimates of the In Vitro Diagnostic industry in Europe. The 2020 edition is based on market size figures of 2019 and also includes macroeconomic and healthcare expenditure data for the EU 27 Member States, UK, as well as for the European Free TradeETHICAL MEDTECH
Medtech Europe. p.rojas@medtecheurope.org. +32 2 775 92 31. Pablo is a Legal & Compliance Manager at MedTech Europe, working on all topics in the Legal & Compliance team, with a focus on the implementation of the MedTech Europe Code of Ethical Business Practice. Pablo’s goal is to provide MedTech Europe members with support on any legal topic MEDTECH EUROPE GUIDANCE FOR ASSIGNING BASIC UDI-DI www.medtecheurope.org Page 1 of 18 GUIDANCE DOCUMENT MedTech Europe guidance for assigning Basic UDI-DI 2 June 2020 v1.1 Aim of the document The MedTech Europe Basic UDI-DI guidance document aims to provide a framework for companies to help FUTURE OF DIABETES CARE t.valentin@medtecheurope.org. Tanja Valentin. Director General. Medtech Europe. t.valentin@medtecheurope.org. +32 2 775 92 36. Tanja leads the External Affairs team at Medtech Europe. She is responsible for both internal and external Communication as well as for the organisation’s Government Affairs & Public Policy work. NEW IVD SYMBOLS FOR COMPLIANCE WITH THE IVDR By 26 May 2022, IVD devices will transition to the new IVD Regulation EU 2017/746. This regulation will require devices intended for self-testing, devices intended for near-patient testing and certain rapid tests (not for self-testing and not for near patient testing) to state these facts on their labels. The use of symbols on the label isan
TO THE EUROPEAN COMMISSION www.medtecheurope.org Page 1 of 2 Brussels, 07 May 2021 To the European Commission Executive Vice-President Dombrovskis and Commissioner Kyriakides Open Letter Re: Call to action to ensure continued supply of medical technologies between the EU and DETERMINING THE PATH FOR ASSESSMENT OF A COMPANION Determining the Path for Assessment of a Companion Diagnostic (CDx) under the In Vitro Diagnostic Medical Devices Regulation Introduction In May 2017, the Regulations on in vitro diagnostic medical devices entered into force in Europe: Regulation 2017/746 on in vitro diagnostic medical devices (IVDR). REVISED MANUFACTURER INCIDENT REPORTING FORM AND NEW The European Commission has published on its website the updated Manufacturer Incident Report (MIR) package which consists of the following documents: • New manufacturer incident report (v7.2 PDF form) • New manufacturer incident report for importing XML file with Adobe Professional • New manufacturer incident report XSD files (for implementation in manufacturer’ databases) • NewRESOURCE LIBRARY
Our Priorities MedTech Europe strives to support our dynamic sector in meeting the needs of patients and health systems. To achieve this, we focus on engaging with healthcare stakeholders on key issues from regulations and market access to digital health and Brexit, amongothers.
MEDTECH EUROPE’S FACTS AND FIGURES 2020 MedTech Europe’s Facts and Figures 2020. Medical technology is a crucial driver for Europe’s economic well-being, providing quality employment, and a substantial contribution to Europe’s balance of trade. MedTech Europe’s Facts & Figures publication is an annually updated report with robust industry data compiled from multiplesources.
OPHTHALMOLOGY
Medtech Europe. n.vanmele@medtecheurope.org. +32 2 775 92 37. Nicolas leads the Finance, HR and Operations team since 2014. The team’s objective is to support the growth of the organization and its smooth operations, to continuously improve its internal processes, and to make sure it has the appropriate resources and the best people to NEW MEDICAL TECHNOLOGY REGULATIONS New EU Regulations governing medical devices (MD) and in vitro diagnostic (IVD) were published in May 2017. MedTech Europe is working with our members and the authorities to support companies in complying with the new legislation by the end of the transition periods – 2021 for MDs and 2022 for IVDs.RESOURCE LIBRARY
Resource Library. Learn more about medical technology and healthcare. Find position papers, infographics, videos, market data and more. -Page 20 of 35
MEDTECH EUROPE'S GUIDANCE ON BASIC UDI-DI ASSIGNMENT The MedTech Europe renders its Basic UDI-DI guidance document public for the benefit of all stakeholders involved in the Basic UDI-DI assignment and assessment such as manufacturers, system or procedure pack producers, issuing agencies and notified bodies.. The guidance primarily aims to provide a framework for companies to help their Basic UDI-DI assignment as per Regulation (EU) MEDTECH EUROPE CODE OF ETHICAL BUSINESS PRACTICE The MedTech Europe Code of Ethical Business Practice regulates all aspects of the industry’s relationship with Healthcare Professionals (HCPs) and Healthcare Organisations (HCOs), to ensure that all interactions are ethical and professional at all times and to maintain the trust of regulators, and – most importantly – patients. ENSURING A SUCCESSFUL TRANSITION TO THE NEW IVD REGULATION www.medtecheurope.org Page 4 of 15 Introduction The IVD industry welcomes the new in vitro Diagnostic Regulation (IVDR) and is fully committed to playing its part to transition to the new CE marking system. The implementation and success of this significant system change require the deployment of necessary NEW IVD SYMBOLS FOR COMPLIANCE WITH THE IVDR By 26 May 2022, IVD devices will transition to the new IVD Regulation EU 2017/746. This regulation will require devices intended for self-testing, devices intended for near-patient testing and certain rapid tests (not for self-testing and not for near patient testing) to state these facts on their labels. The use of symbols on the label isan
MINIMALLY INVASIVE SOLUTIONS FOR ENLARGED PROSTATES Minimally invasive solutions for enlarged prostates. Over 50% of men suffer from an enlarged prostate by age 50, but many suffer in silence through symptoms which adversely impact their quality of life. Water vapour therapy is a simple minimally-invasive solution that can offer relief and long term improvement while also reducing the burden on MEDTECH EUROPE, FROM DIAGNOSIS TO CURE MedTech Europe is the European trade association representing the medical technology industries, from diagnosis to cure. We represent Diagnostics and Medical Devices manufacturers operating in Europe. There are more than 500,000 products, services and solutions currently made available by the medical technology industry. GLOBAL INVITRO DIAGNOSTIC (GIVD) CLASSIFICATION Global InVitro Diagnostic (GIVD) Classification – Version 2021. MedTech Europe has created a specific classification scheme for IVDs, the Global IVD (GIVD) classification (previously known as EDMA classification). It is a numerical coding system, which has been developed for the purpose to support the collection and analysis ofmarket statistics.
ETHICAL MEDTECH
Medtech Europe. p.rojas@medtecheurope.org. +32 2 775 92 31. Pablo is a Legal & Compliance Manager at MedTech Europe, working on all topics in the Legal & Compliance team, with a focus on the implementation of the MedTech Europe Code of Ethical Business Practice. Pablo’s goal is to provide MedTech Europe members with support on any legal topic EUROPEAN IVD MARKET STATISTICS REPORT 2020 European IVD Market Statistics Report 2020. MedTech Europe publishes every year the market estimates of the In Vitro Diagnostic industry in Europe. The 2020 edition is based on market size figures of 2019 and also includes macroeconomic and healthcare expenditure data for the EU 27 Member States, UK, as well as for the European Free Trade MEDTECH EUROPE'S GUIDANCE ON BASIC UDI-DI ASSIGNMENT The MedTech Europe renders its Basic UDI-DI guidance document public for the benefit of all stakeholders involved in the Basic UDI-DI assignment and assessment such as manufacturers, system or procedure pack producers, issuing agencies and notified bodies.. The guidance primarily aims to provide a framework for companies to help their Basic UDI-DI assignment as per Regulation (EU) MEDTECH EUROPE CODE OF ETHICAL BUSINESS PRACTICE The MedTech Europe Code of Ethical Business Practice regulates all aspects of the industry’s relationship with Healthcare Professionals (HCPs) and Healthcare Organisations (HCOs), to ensure that all interactions are ethical and professional at all times and to maintain the trust of regulators, and – most importantly – patients. Itbecame
MEDTECH EUROPE GUIDANCE FOR ASSIGNING BASIC UDI-DI www.medtecheurope.org Page 1 of 18 GUIDANCE DOCUMENT MedTech Europe guidance for assigning Basic UDI-DI 2 June 2020 v1.1 Aim of the document The MedTech Europe Basic UDI-DI guidance document aims to provide a framework for companies to help TO THE EUROPEAN COMMISSION www.medtecheurope.org Page 1 of 2 Brussels, 07 May 2021 To the European Commission Executive Vice-President Dombrovskis and Commissioner Kyriakides Open Letter Re: Call to action to ensure continued supply of medical technologies between the EU and COBALT IN ORTHOPAEDIC IMPLANTS Page 1 of 2 Cobalt in Orthopaedic Implants Joint Statement of EFORT and MedTech Europe’s Orthopaedic Sector Group 14 August 2018 Under the new Medical Devices Regulation1, orthopaedic implants containing Cobalt (usually in alloy form) will most likely have to bear a CONFERENCE VETTING SYSTEM Posted on 29.08.2015. Eucomed’s Conference Vetting System is an independently managed system that reviews the compliance of third-party educational conferences with the Eucomed Code of Ethical Business Practice, based on clear and objective criteria. For more information, please go to www.ethicalmedtech.eu. MEDTECH EUROPE, FROM DIAGNOSIS TO CURE MedTech Europe is the European trade association representing the medical technology industries, from diagnosis to cure. We represent Diagnostics and Medical Devices manufacturers operating in Europe. There are more than 500,000 products, services and solutions currently made available by the medical technology industry. GLOBAL INVITRO DIAGNOSTIC (GIVD) CLASSIFICATION Global InVitro Diagnostic (GIVD) Classification – Version 2021. MedTech Europe has created a specific classification scheme for IVDs, the Global IVD (GIVD) classification (previously known as EDMA classification). It is a numerical coding system, which has been developed for the purpose to support the collection and analysis ofmarket statistics.
ETHICAL MEDTECH
Medtech Europe. p.rojas@medtecheurope.org. +32 2 775 92 31. Pablo is a Legal & Compliance Manager at MedTech Europe, working on all topics in the Legal & Compliance team, with a focus on the implementation of the MedTech Europe Code of Ethical Business Practice. Pablo’s goal is to provide MedTech Europe members with support on any legal topic EUROPEAN IVD MARKET STATISTICS REPORT 2020 European IVD Market Statistics Report 2020. MedTech Europe publishes every year the market estimates of the In Vitro Diagnostic industry in Europe. The 2020 edition is based on market size figures of 2019 and also includes macroeconomic and healthcare expenditure data for the EU 27 Member States, UK, as well as for the European Free Trade MEDTECH EUROPE'S GUIDANCE ON BASIC UDI-DI ASSIGNMENT The MedTech Europe renders its Basic UDI-DI guidance document public for the benefit of all stakeholders involved in the Basic UDI-DI assignment and assessment such as manufacturers, system or procedure pack producers, issuing agencies and notified bodies.. The guidance primarily aims to provide a framework for companies to help their Basic UDI-DI assignment as per Regulation (EU) MEDTECH EUROPE CODE OF ETHICAL BUSINESS PRACTICE The MedTech Europe Code of Ethical Business Practice regulates all aspects of the industry’s relationship with Healthcare Professionals (HCPs) and Healthcare Organisations (HCOs), to ensure that all interactions are ethical and professional at all times and to maintain the trust of regulators, and – most importantly – patients. Itbecame
MEDTECH EUROPE GUIDANCE FOR ASSIGNING BASIC UDI-DI www.medtecheurope.org Page 1 of 18 GUIDANCE DOCUMENT MedTech Europe guidance for assigning Basic UDI-DI 2 June 2020 v1.1 Aim of the document The MedTech Europe Basic UDI-DI guidance document aims to provide a framework for companies to help TO THE EUROPEAN COMMISSION www.medtecheurope.org Page 1 of 2 Brussels, 07 May 2021 To the European Commission Executive Vice-President Dombrovskis and Commissioner Kyriakides Open Letter Re: Call to action to ensure continued supply of medical technologies between the EU and COBALT IN ORTHOPAEDIC IMPLANTS Page 1 of 2 Cobalt in Orthopaedic Implants Joint Statement of EFORT and MedTech Europe’s Orthopaedic Sector Group 14 August 2018 Under the new Medical Devices Regulation1, orthopaedic implants containing Cobalt (usually in alloy form) will most likely have to bear a CONFERENCE VETTING SYSTEM Posted on 29.08.2015. Eucomed’s Conference Vetting System is an independently managed system that reviews the compliance of third-party educational conferences with the Eucomed Code of Ethical Business Practice, based on clear and objective criteria. For more information, please go to www.ethicalmedtech.eu.RESOURCE LIBRARY
Our Priorities MedTech Europe strives to support our dynamic sector in meeting the needs of patients and health systems. To achieve this, we focus on engaging with healthcare stakeholders on key issues from regulations and market access to digital health and Brexit, amongothers.
MEDTECH EUROPE’S FACTS AND FIGURES 2020 MedTech Europe’s Facts and Figures 2020. Medical technology is a crucial driver for Europe’s economic well-being, providing quality employment, and a substantial contribution to Europe’s balance of trade. MedTech Europe’s Facts & Figures publication is an annually updated report with robust industry data compiled from multiplesources.
MEDTECH EUROPE'S GUIDANCE ON BASIC UDI-DI ASSIGNMENT The MedTech Europe renders its Basic UDI-DI guidance document public for the benefit of all stakeholders involved in the Basic UDI-DI assignment and assessment such as manufacturers, system or procedure pack producers, issuing agencies and notified bodies.. The guidance primarily aims to provide a framework for companies to help their Basic UDI-DI assignment as per Regulation (EU)RESOURCE LIBRARY
Resource Library. Learn more about medical technology and healthcare. Find position papers, infographics, videos, market data and more. -Page 13 of 35
FUTURE OF DIABETES CARE t.valentin@medtecheurope.org. Tanja Valentin. Director General. Medtech Europe. t.valentin@medtecheurope.org. +32 2 775 92 36. Tanja leads the External Affairs team at Medtech Europe. She is responsible for both internal and external Communication as well as for the organisation’s Government Affairs & Public Policy work. SYNDIGO - MEDTECH EUROPE Our Priorities MedTech Europe strives to support our dynamic sector in meeting the needs of patients and health systems. To achieve this, we focus on engaging with healthcare stakeholders on key issues from regulations and market access to digital health and Brexit, amongothers.
ENSURING A SUCCESSFUL TRANSITION TO THE NEW IVD REGULATION www.medtecheurope.org Page 4 of 15 Introduction The IVD industry welcomes the new in vitro Diagnostic Regulation (IVDR) and is fully committed to playing its part to transition to the new CE marking system. The implementation and success of this significant system change require the deployment of necessary MEDTECH EUROPE GUIDANCE ON SYMBOLS FOR MDR LABELS IS PUBLISHED MedTech Europe guidance on symbols for MDR labels is published. Posted on 06.06.2019. This key piece of guidance to facilitate MDR implementation has been prepared through intense work by the MTE Labelling WG (MD) and is now available for your use at this link. The graphical symbols in this guidance have been validated by healthcare REVISED MANUFACTURER INCIDENT REPORTING FORM AND NEW The European Commission has published on its website the updated Manufacturer Incident Report (MIR) package which consists of the following documents: • New manufacturer incident report (v7.2 PDF form) • New manufacturer incident report for importing XML file with Adobe Professional • New manufacturer incident report XSD files (for implementation in manufacturer’ databases) • New CARDIOVASCULAR DISEASE BURDEN IN EUROPE Cardiovascular Disease Burden in Europe – A call to action. Diseases of the heart and circulatory system are the leading cause of death in Europe and a major cause of disability. Cardiovascular diseases can impact people of all ages. However, the risk of cardiovascular disease, which includes heart failure, atrial fibrillation-relatedstroke
MEDTECH EUROPE, FROM DIAGNOSIS TO CURE MedTech Europe is the European trade association representing the medical technology industries, from diagnosis to cure. We represent Diagnostics and Medical Devices manufacturers operating in Europe. There are more than 500,000 products, services and solutions currently made available by the medical technology industry. GLOBAL INVITRO DIAGNOSTIC (GIVD) CLASSIFICATION Global InVitro Diagnostic (GIVD) Classification – Version 2021. MedTech Europe has created a specific classification scheme for IVDs, the Global IVD (GIVD) classification (previously known as EDMA classification). It is a numerical coding system, which has been developed for the purpose to support the collection and analysis ofmarket statistics.
NEW MEDICAL TECHNOLOGY REGULATIONS New EU Regulations governing medical devices (MD) and in vitro diagnostic (IVD) were published in May 2017. MedTech Europe is working with our members and the authorities to support companies in complying with the new legislation by the end of the transition periods – 2021 for MDs and 2022 for IVDs. EUROPEAN IVD MARKET STATISTICS REPORT 2020 European IVD Market Statistics Report 2020. MedTech Europe publishes every year the market estimates of the In Vitro Diagnostic industry in Europe. The 2020 edition is based on market size figures of 2019 and also includes macroeconomic and healthcare expenditure data for the EU 27 Member States, UK, as well as for the European Free Trade MEDTECH EUROPE GUIDANCE FOR ASSIGNING BASIC UDI-DI www.medtecheurope.org Page 1 of 18 GUIDANCE DOCUMENT MedTech Europe guidance for assigning Basic UDI-DI 2 June 2020 v1.1 Aim of the document The MedTech Europe Basic UDI-DI guidance document aims to provide a framework for companies to help MEDTECH EUROPE CODE OF ETHICAL BUSINESS PRACTICE The MedTech Europe Code of Ethical Business Practice regulates all aspects of the industry’s relationship with Healthcare Professionals (HCPs) and Healthcare Organisations (HCOs), to ensure that all interactions are ethical and professional at all times and to maintain the trust of regulators, and – most importantly – patients. Itbecame
TO THE EUROPEAN COMMISSION www.medtecheurope.org Page 1 of 2 Brussels, 07 May 2021 To the European Commission Executive Vice-President Dombrovskis and Commissioner Kyriakides Open Letter Re: Call to action to ensure continued supply of medical technologies between the EU and REVISED MANUFACTURER INCIDENT REPORTING FORM AND NEW The European Commission has published on its website the updated Manufacturer Incident Report (MIR) package which consists of the following documents: • New manufacturer incident report (v7.2 PDF form) • New manufacturer incident report for importing XML file with Adobe Professional • New manufacturer incident report XSD files (for implementation in manufacturer’ databases) • New THE TRANSITION TO A NEW REGULATORY FRAMEWORK FOR MEDICAL From May 2017 to May 2020, Medical Devices will start to transition from being CE marked under the two current (and separate) Medical Devices Directives – Directive 93/442/EEC and Directive 90/385/EEC to being CE marked under the new Medical Devices Regulation (EU) 2017/745. However, the transition may last until at least May 2024 forthose
CONFERENCE VETTING SYSTEM Posted on 29.08.2015. Eucomed’s Conference Vetting System is an independently managed system that reviews the compliance of third-party educational conferences with the Eucomed Code of Ethical Business Practice, based on clear and objective criteria. For more information, please go to www.ethicalmedtech.eu. MEDTECH EUROPE, FROM DIAGNOSIS TO CURE MedTech Europe is the European trade association representing the medical technology industries, from diagnosis to cure. We represent Diagnostics and Medical Devices manufacturers operating in Europe. There are more than 500,000 products, services and solutions currently made available by the medical technology industry. GLOBAL INVITRO DIAGNOSTIC (GIVD) CLASSIFICATION Global InVitro Diagnostic (GIVD) Classification – Version 2021. MedTech Europe has created a specific classification scheme for IVDs, the Global IVD (GIVD) classification (previously known as EDMA classification). It is a numerical coding system, which has been developed for the purpose to support the collection and analysis ofmarket statistics.
NEW MEDICAL TECHNOLOGY REGULATIONS New EU Regulations governing medical devices (MD) and in vitro diagnostic (IVD) were published in May 2017. MedTech Europe is working with our members and the authorities to support companies in complying with the new legislation by the end of the transition periods – 2021 for MDs and 2022 for IVDs. EUROPEAN IVD MARKET STATISTICS REPORT 2020 European IVD Market Statistics Report 2020. MedTech Europe publishes every year the market estimates of the In Vitro Diagnostic industry in Europe. The 2020 edition is based on market size figures of 2019 and also includes macroeconomic and healthcare expenditure data for the EU 27 Member States, UK, as well as for the European Free Trade MEDTECH EUROPE CODE OF ETHICAL BUSINESS PRACTICE The MedTech Europe Code of Ethical Business Practice regulates all aspects of the industry’s relationship with Healthcare Professionals (HCPs) and Healthcare Organisations (HCOs), to ensure that all interactions are ethical and professional at all times and to maintain the trust of regulators, and – most importantly – patients. Itbecame
MEDTECH EUROPE GUIDANCE FOR ASSIGNING BASIC UDI-DI www.medtecheurope.org Page 1 of 18 GUIDANCE DOCUMENT MedTech Europe guidance for assigning Basic UDI-DI 2 June 2020 v1.1 Aim of the document The MedTech Europe Basic UDI-DI guidance document aims to provide a framework for companies to help TO THE EUROPEAN COMMISSION www.medtecheurope.org Page 1 of 2 Brussels, 07 May 2021 To the European Commission Executive Vice-President Dombrovskis and Commissioner Kyriakides Open Letter Re: Call to action to ensure continued supply of medical technologies between the EU and REVISED MANUFACTURER INCIDENT REPORTING FORM AND NEW The European Commission has published on its website the updated Manufacturer Incident Report (MIR) package which consists of the following documents: • New manufacturer incident report (v7.2 PDF form) • New manufacturer incident report for importing XML file with Adobe Professional • New manufacturer incident report XSD files (for implementation in manufacturer’ databases) • New THE TRANSITION TO A NEW REGULATORY FRAMEWORK FOR MEDICAL From May 2017 to May 2020, Medical Devices will start to transition from being CE marked under the two current (and separate) Medical Devices Directives – Directive 93/442/EEC and Directive 90/385/EEC to being CE marked under the new Medical Devices Regulation (EU) 2017/745. However, the transition may last until at least May 2024 forthose
CONFERENCE VETTING SYSTEM Posted on 29.08.2015. Eucomed’s Conference Vetting System is an independently managed system that reviews the compliance of third-party educational conferences with the Eucomed Code of Ethical Business Practice, based on clear and objective criteria. For more information, please go to www.ethicalmedtech.eu. ABOUT US - MEDTECH EUROPE, FROM DIAGNOSIS TO CURE About us. MedTech Europe is the European trade association for the medical technology industry including diagnostics, medical devices and digital health. MedTech Europe’s mission is to make innovative medical technology available to more people, while helping healthcare systems move towards a sustainable path. MedTech Europe encouragesETHICAL MEDTECH
Medtech Europe. p.rojas@medtecheurope.org. +32 2 775 92 31. Pablo is a Legal & Compliance Manager at MedTech Europe, working on all topics in the Legal & Compliance team, with a focus on the implementation of the MedTech Europe Code of Ethical Business Practice. Pablo’s goal is to provide MedTech Europe members with support on any legal topicOPHTHALMOLOGY
Medtech Europe. n.vanmele@medtecheurope.org. +32 2 775 92 37. Nicolas leads the Finance, HR and Operations team since 2014. The team’s objective is to support the growth of the organization and its smooth operations, to continuously improve its internal processes, and to make sure it has the appropriate resources and the best people toRESOURCE LIBRARY
Resource Library. Learn more about medical technology and healthcare. Find position papers, infographics, videos, market data and more.FACTS & FIGURES
Facts & Figures. The medical technology industry continues to be one of Europe’s most diverse and innovative sectors. This can be seen in the high number of patents filed by medtech companies, as well as in data on trade flows and employment statistics. Capturing the activity our large and diverse industry is vital for healthcare stakeholders GLOBAL INVITRO DIAGNOSTIC (GIVD) CLASSIFICATION Global InVitro Diagnostic (GIVD) Classification – Version 2021. MedTech Europe has created a specific classification scheme for IVDs, the Global IVD (GIVD) classification (previously known as EDMA classification). It is a numerical coding system, which has been developed for the purpose to support the collection and analysis ofmarket statistics.
MEDTECH EUROPE'S GUIDANCE ON BASIC UDI-DI ASSIGNMENT The MedTech Europe renders its Basic UDI-DI guidance document public for the benefit of all stakeholders involved in the Basic UDI-DI assignment and assessment such as manufacturers, system or procedure pack producers, issuing agencies and notified bodies.. The guidance primarily aims to provide a framework for companies to help their Basic UDI-DI assignment as per Regulation (EU)RESOURCE LIBRARY
Resource Library. Learn more about medical technology and healthcare. Find position papers, infographics, videos, market data and more. -Page 14 of 35
FINANCING OF MEDICAL TECHNOLOGY Medtech Europe. s.koettlitz@medtecheurope.org. +32 474 888 961. Sophie is a Manager Market Access & Economic Policies. She is responsible for activities and projects focusing on the topics of (public) procurement and Financing of Medical Technology. Sophie’s goal is to help members in navigating the complex market access medical technology MARKET DATA MEDICAL DEVICES Medical Device Market Trackers. The Market Data team is an integral part of MedTech Europe. Its 25 ongoing Market Data Trackers provide an opportunity for participating companies to enhance their understanding of the markets and to pinpoint trends in those markets. Skip to main content We value your privacy We use cookies to speed up your navigation of the website, recognize you and your access privileges, and track your website usage. We may use third-party companies to further customise your experience and make it more relevant to your needs and interests, both on this website and third-party platforms.I accept Learn more
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Press Release Digital Health MEDTECH EUROPE LAUNCHES A NEW REPORT ON THE IMPACT OF ARTIFICIAL INTELLIGENCE IN HEALTHCARE Posted on 27.10.2020Read more
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Event Value-Based Procurement 2ND EUROPEAN VALUE-BASED PROCUREMENT CONFERENCE Tuesday 1st December 2020 Organised by the Value-Based Procurement Community of Practice and supported by EHPPA, EUREGHA, and MedTech Europe, the 2nd European Value-Based Procurement conference aims at bringing together European stakeholders to discuss the shift to a value-based approach that will put patient benefits at the centre of purchasing decisions.Read more
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WHEN MEDTECH GIVES YOU GOOD NEWS Last year, I was having some pain in my left breast and it felt like there were some physical changes, so my doctor recommended that I havea mammogram.
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IN CRISIS, MEDTECH FOUND THE PATH TO REALISE ITS FULL POTENTIAL I have been truly humbled by the collective response of the medical technology industry through this pandemic.Read more
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You can contact us at data.protection@medtecheurope.org for further questions related to your privacy and your rights.ABOUT US
MEDTECH EUROPE IS THE EUROPEAN TRADE ASSOCIATION REPRESENTING THE MEDICAL TECHNOLOGY INDUSTRIES, FROM DIAGNOSIS TO CURE. We represent Diagnostics and Medical Devices manufacturers operating in Europe. There are more than 500,000 products, services and solutions currently made available by the medical technology industry. These range from bandages, blood tests and hearing aids to cancer screening tests, pacemakers and glucose monitors. Our sector employs more than 730,000 people. There are more than 32,000 medical technology companies in Europe, of which 95% are SMEs.Read more Members
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INTERACTIONS WITH THE MEDICAL COMMUNITY INTERACTIONS WITH THE MEDICAL COMMUNITY The medical technology industry is expected to find new ways to keep us healthy, and to do so in a responsible manner. MedTech Europe and its members are committed to a high level of ethical business practices and have put in place strict guidelines to advise medical technology manufacturers on how to collaborate ethically with healthcare professionals (HCPs).Explore
BREXIT
BREXIT
Brexit is a critical topic for the medical technology industry which has developed highly complex ties between the United Kingdom (UK) and the rest of the EU. Medical technologies are often moved between different EU countries during their production lifecycle and their clinical use. Crucially, up to 30% of our industry’s products have been authorised via UK Notified Bodies (CE marking) and could lose such authorisation overnight in the case of a “cliff edge” Brexit. MedTech Europe is tracking developments closely and has produced a position paper and other relevant documents to help medtech companiesto navigate Brexit.
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ACCESS TO MEDICAL TECHNOLOGY ACCESS TO MEDICAL TECHNOLOGY Medical technologies have the potential to save and improve lives, to inform citizens on the state of their health and to guide healthcaredelivery.
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NEW MEDICAL TECHNOLOGY REGULATIONS NEW MEDICAL TECHNOLOGY REGULATIONS Medical technologies are tightly regulated in the European Union. Before a medical technology can be legally placed on the EU market, a manufacturer must comply with the requirements of all applicable EU legislation and affix a CE mark to their device. New EU Regulations governing medical devices (MD) and in vitro diagnostic (IVD) were published in May 2017. MedTech Europe is working with our members and the authorities to support companies in complying with the new legislation by the end of the transition periods – 2021 for MDs and 2022 for IVDs.Explore
COVID-19 INFORMATION HUB COVID-19 INFORMATION HUB Dear Members, Partners, Friends, We created the COVID-19 information hub to provide you with relevant information on activities of the medical technology manufacturers, the European Union and the Member States in addressing the Coronavirus pandemic. We will keep updating this section as the situation continues to develop. Scroll through the page to find useful links, contact information and materials. To all of you, stay safe andhealthy!
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HOMECARE & COMMUNITY CARE HOMECARE & COMMUNITY CARE The MedTech industry develops products that facilitate the delivery of health services in the community care setting and in people's homes. These technologies save lives, are convenient for patients and make efficient use of healthcare resources.Explore
ENVIRONMENTAL AND SOCIAL SUSTAINABILITY ENVIRONMENTAL AND SOCIAL SUSTAINABILITY In addition to the medical technology sector’s core goal of saving lives and improving health, environmental and social considerations are an integral part of our industry’s operations. We acknowledge that preserving a healthy environment and building socially responsible value chains are essential in keeping human beings in good health. Our industry needs to be at the forefront of addressing challenges related to sustainable healthcare.Explore
MARKET DATA
MARKET DATA
Information is power. Medical technology companies need to stay on top of the latest trends impacting their business. Informed decisions require up-to-date market intelligence from a trusted service.Explore
DIGITAL HEALTH
DIGITAL HEALTH
Medical technologies generate information and data that are critical for the prevention, diagnosis, treatment, monitoring and management of health and lifestyle. More and more of this data is now digitised; it can be stored and accessed on electronic health records and personal devices, shared among patients and healthcare professionals, and aggregated and processed with data advanced analytics MedTech Europe works with policymakers and relevant stakeholders to realise the potential of data-driven healthcare. Together we focus on legal and regulatory issues (privacy, safety), technology (cybersecurity, interoperability), the business case (incentives, reimbursement), and emerging technologies (precision medicine, artificial intelligence).Explore
INTERNATIONAL
INTERNATIONAL
MedTech Europe engages with global agencies, decision-makers and stakeholders on key international issues facing medical technologycompanies.
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RESEARCH AND INNOVATION RESEARCH AND INNOVATION Research & Innovation (R&I) is the lifeblood of Europe’s medical technology sector. Industry investment in R&I delivers life-enhancing devices, diagnostics and digital solutions. EU support for R&I offers valuable opportunities for academia and industry to generate new knowledge and use it to tackle the biggest challenges facing our societies. The quest for tomorrow’s healthcare innovations demands new, broad partnerships. R&I is most impactful when it is based on collaboration. MedTech Europe is committed to working with others in the public and private sectors to find shared solutions to our commonchallenges.
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OPHTHALMOLOGY
OPHTHALMOLOGY
Vision loss can have a profound impact on those affected, resulting in lost independence and significantly limiting daily activities. Ageing increases the risk of eye diseases that can lead to visual impairment. The MedTech industry develops products that reduce the burden of eye disease on individuals, families and the wider economy. These innovations add enormous value to European society.Explore
ANTIMICROBIAL RESISTANCE (AMR) AND HEALTHCARE ASSOCIATED INFECTIONS(HAIS)
ANTIMICROBIAL RESISTANCE (AMR) AND HEALTHCARE ASSOCIATED INFECTIONS(HAIS)
Antimicrobial Resistance (AMR) and Healthcare Associated Infections (HAI) are among the biggest global public health challenges of our time. These infections cause significant morbidity and mortality, put pressure on health systems, and incur rising direct and indirectcosts.
Medical technologies can help to address these problems by preventing, detecting, monitoring and managing infections and resistance.Explore
CARDIOVASCULAR
CARDIOVASCULAR
Cardiovascular diseases can impact millions of people of all ages. Diseases of the heart and circulatory system are the leading cause of death in Europe and a major cause of disability. The medical technology industry provides high-quality solutions to the burden of cardiovascular diseases on individuals, families and the wider society. These innovations, which span the full spectrum of patient care from diagnosis to cure, save lives and add tremendous value to European society.Explore
ORTHOPAEDIC
ORTHOPAEDIC
Orthopaedics is the medical specialty that focuses on injuries and diseases of the human body's musculoskeletal system. This complex system includes your bones, joints, ligaments, tendons, muscles, and nerves and allows you to move, work, and be active. The MedTech industry develops products that reduce the burden of musculoskeletal diseases on individuals, families and the wider economy. These innovations improve quality of life and add enormous value to European society.Explore
DIABETES
DIABETES
1 in 11 adults around the world have diabetes. That’s about 60 million people across Europe, equivalent to the total Italian population. This number increases significantly every year. If current trends continue, diabetes will be the number one health threat in thecoming years.
The European Diabetes Sector Group aims to reverse this trend by taking meaningful collective action to help avoid the diabetes pandemic where possible, and when diagnosis occurs to put people at the centre of care and give them back a full and fear-free life.Explore
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