Skip to main content

MedTech Europe survey on eIFUs for IVDs (deadline: 17 May 2024)

By MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive
MedTech Europe are conducting a survey for Europe based users of Near-Patient Testing devices (e.g. Medical Doctors, Physicians, Nursing staff, Operators, Pharmacy staff, Emergency Room staff, Ambulance staff) on the subject of electronic instructions for use (IFU) for Near-Patient Testing devices. This survey will provide invaluable insights into the practice in the healthcare field in the EU. Why are MedTech…
Read More
January 24, 2024 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

BioMedical Alliance publishes a statement on shortage of diagnostic tests

The European BioMedical Alliance (36 leading European medical societies that together include more than 400,000 researchers and health professionals) along with the European Federation of Clinical Chemistry & Laboratory Medicine (EFLM) have published a Statement: “Urgent action needed to prevent widespread shortage of diagnostic tests”. This document points to the persisting problems with the implementation of EU IVDR. It calls…
Read More
November 24, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

MedTech Europe RAC

This week, BIVDA was represented at MedTech Europe Regulatory Affairs Committee (RAC) by Stuart and Tehelj. The meeting was also attended by members of the European Commission. It was a constructive meeting with a focus on the published paper on the Future of Europe's Medical Technology Regulation, and the continued challenges on the transition to the EU IVD Regulation.
Read More
November 17, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

MedTech Europe position paper published: The Future of Europe’s Medical Technology Regulations

MedTech Europe have published a position paper The Future of Europe’s Medical Technology Regulations. This paper describes MedTech Europe’s vision for an efficient, innovation-focused, and well-governed regulatory framework. It addresses healthcare access challenges resulting from the structural issues of the European regulatory system. MedTech Europe has called out for comprehensive reform addressing the three key areas of efficiency, innovation and…
Read More
November 17, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

EPSCO meeting to be held on 30 Nov

Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) is the meeting of the EU Ministers of Health. The upcoming EPSCO meeting agenda includes the implementation of IVDR and MDR with information from the French delegation, supported by the Belgian, German, Irish and Italian delegations. EPSCO is the meeting of the EU Ministers of Health. A public debate is proposed.…
Read More
November 10, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

MedTech Europe position paper published: The Future of Europe’s Medical Technology Regulations

MedTech Europe have published a position paper The Future of Europe’s Medical Technology Regulations. This paper describes MedTech Europe’s vision for an efficient, innovation-focused, and well-governed regulatory framework. It addresses healthcare access challenges resulting from the structural issues of the European regulatory system. MedTech Europe has called out for comprehensive reform addressing the three key areas of efficiency, innovation and…
Read More
October 27, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

TEAM-NB Notified Bodies call to action to manufacturers to apply

Team-NB hve published a press release "TEAM-NB Notified Bodies call to action to manufacturers to apply. October 2023" This press release is a call to action to to apply with notified bodies in time especially for high-risk IVD medical devices. It intends to raise awareness with the device manufacturers and other economic operators to apply with notified bodies in time.…
Read More
May 12, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

EU Notified bodies urging to submit Class D legacy devices’ application sooner

As the transitional deadlines for IVD devices are fast approaching, the Notified Bodies have communicated with MedTech Europe to encourage manufacturers to submit their applications for compliance with the IVD Regulation as early as possible. Manufacturers are urged to submit applications for Class D legacy devices before end-2023, in order to meet the deadline of 26 May 2025.
Read More
March 9, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

EU MDR/EU IVDR amendment approved by EU Council

On 7 March, the European Council unanimously approved the amendment to the EU MDR and EU IVDR. This amends the transitional provisions for the MDR and removes the sell-off provision for IVDs. This is expected to be published in the Official Journal of the European Union this month, which will be when it comes into force. MedTech Europe's press release…
Read More
March 9, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

Team-NB position paper published: guidance for submission of technical documentation

Team-NB have published the position paper Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Device Regulation (EU) 2017/746. This is listed as "Team-NB PositionPaper BPG-IVDR V1" on the Team-NB website. Please note that although this is a guidance document published by a collective group of Notified Bodies, it is…
Read More
March 9, 2023 in MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

MedTech Europe survey results: Transition to the IVD Regulation

MedTech Europe have published their Survey Report Transition to the IVD Regulation - MedTech Europe Survey Results for October 2022. This report can be found on the MedTech Europe website. The results demonstrate that there are still bottlenecks occurring throughout the IVDR implementation, and indicates where additional attention is needed.    
Read More
March 9, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

EMA pilot launched for expert panels on high risk medical devices

For class III implantable devices, class IIb active devices intended to administer or remove medicinal products from the body, and Class D in vitro diagnostic medical devices, the Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) require notified bodies to consult expert panels before issuing a CE certificate. EMA is now running a pilot that enables the expert panels to…
Read More
March 9, 2023 in MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

Third edition of Clinical Evidence Requirements under the IVDR eBook published

MedTech Europe have published the third version of their Clinical Evidence Requirements under the EU In Vitro Diagnostics Regulation eBook. This can be found on the MedTech Europe website.
Read More