12.11.2019
Newsletter
MDR/IVDR – what’s new?
As preparations continue for the application of the new Medical Devices Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR), now is a good time to update you on the latest news and recent developments.
In this issue:
- Notified Bodies designated to date
- Call for experts on medical devices and in vitro diagnostic medical devices
- Shedding light on the UDI system
- Factsheet for Healthcare Professionals and Health Institutions now available
- Stay tuned for future updates!
Notified Bodies designated to date
To date, a total of five Notified Bodies have been designated to certify medical devices under the new Regulations and one Notified Body has been designated to certify in-vitro diagnostic medical devices. These are:
Medical Devices
- British business standards company BSI Assurance UK Ltd;
- Italy’s IMQ - Istituto Italiano Del Marchio Di Qualità S.P.A.;
- Stuttgart-based DEKRA Certification GmbH;
- Nuremberg-based TÜV and Rheinland LGA Products GmbH;
- TÜV SÜD Product Service GmbH Zertifizierstellen, from Munich.
In-vitro Diagnostic Medical Devices
- Stuttgart-based DEKRA Certification GmbH.
To keep up to date on Notified Bodies as they are designated, check the NANDO database here.
Call for experts on medical devices and in vitro diagnostic medical devices
The European Commission has published a call for expression of interest to appoint advisors to expert panels for the provision of scientific, technical and/or clinical advice on the implementation of the Medical Devices Regulation. If you wish to be considered as advisor to the expert panels in the first cycle of appointments, please submit a complete application with supporting documents by 10 November 2019.
Read more here.
Shedding light on the UDI system
A new UDI system is being established by the new Regulations. This will apply to all medical devices except for custom-made and performance study/investigational devices. The new system is based on internationally recognised principles, notably by using definitions that are compatible with those used by major trade partners.
The Unique Device Identification (UDI) system will facilitate easier traceability of medical devices, significantly enhance the effectiveness of post-market safety-related activities for devices and allow for better monitoring by competent authorities. It will also help to reduce medical errors and to fight against falsified devices. The use of the UDI system should also improve purchasing and waste disposal policies and stock-management by health institutions and other economic operators.
To explain the UDI system and how it will be applied, we have prepared a set of frequently asked questions.
Read more here.
Factsheet for Healthcare Professionals and Health Institutions now available
A new factsheet aimed at healthcare professionals and health institutions is now available, to help them prepare for the application of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). After a brief introduction of the new Regulations, the factsheet goes on to explain in detail the implications of the new Regulations and what they mean in practice for healthcare professionals and institutions.
Read more here.
Stay tuned for future updates!
We will keep you informed about when new resources become available.
Make sure to check the Medical Devices section on the DG GROW website for updates on the upcoming application on the MDR and IVDR.
On the portal you can also find a large database of documents and links to websites with new information on the MDR and IVDR, in addition to factsheets, step-by-step guides and other resources such as visuals, web banners and infographics, which all those involved with medical devices and in vitro diagnostic devices can use freely to spread the message and inform their stakeholders.
We will publish some new factsheets in the near future. To receive notifications about future publications or newsletters, please sign up here.
On the website, you can also provide feedback on the information provided. Help us to help you, by providing your feedback here.
