Medical devices legislation is changing: Are you ready?

The new Medical Devices Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR) officially entered into force on 26 May 2017, bringing with them a number of new responsibilities for stakeholders – some of which have already kicked in. To help you prepare, the European Commission’s Directorate General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) has launched a web portal, providing an extensive source of information on the new Regulations.

The MDR and IVDR officially entered into force on 26 May 2017 and the new rules will start to apply three years after this date for the MDR, on 26 May 2020, and five years later for the IVDR – on 26 May 2022. However some rules already apply, such as the new requirements on Notified Bodies designated under the new Regulations and the provisions of the new governance structure. It is already possible to place a MDR/IVDR compliant devices on the market.

Months left before the date of application of the MDR: 14

Months  left before the date of application of the IVDR: 38

In this newsletter:

Benefits and responsibilities

The new Regulations bring significant benefits for patients, providing better protection of public health and patient safety. However, hand-in-hand with these benefits come a range of new responsibilities for stakeholders. The new rules impose tighter controls on high-risk devices such as implants, for example. Controls are also being tightened on clinical investigations for medical devices and performance studies for in vitro medical devices as well as on the Notified Bodies that can deliver certificates for medical devices.

To keep all stakeholders informed of their roles and responsibilities under the new Regulation and to help them to prepare in time for their application, the European Commission has launched a new Medical Devices section on the DG GROW website with some documents and information provided in all European Union languages and some other non-European Union languages, such as Russian, Chinese, Japanese and Arabic. This portal acts as a one-stop-shop for information on the new Regulations, with sections dedicated to all stakeholders along the medical devices and in vitro diagnostic medical devices chain.

Extensive database

The new portal also contains a large database of documents and links to websites with information on the MDR and IVDR, in addition to factsheets, step-by-step guides and other resources such as social media images, 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.

The library of external resources related to medical devices and in-vitro medical devices has been updated on the DG GROW medical devices portal. The Library is your entry point to a comprehensive database of documents produced by stakeholders throughout the European Union, in addition to all relevant websites. The Library also includes key resources produced by DG GROW related to the Regulations on medical devices and in-vitro medical devices, as well as information on financing programmes from the European Union for SMEs.

To search through the library, click here.

BSI becomes first Notified Body designated under Europe's MDR

Under the new Medical Devices Regulation (EU) 2017/745 all devices, except for Class I self-certified devices, require new certification by a Notified Body (NB). NBs can only certify for the MDR if they are designated for this purpose. This is a complex and time-consuming process that has, already 14 months after its start, resulted in the first NB designated for the MDR. The British Notified Body BSI-UK is the first to cross the line, as can be seen in the European Database for Notified Bodies, NANDO.

New Brexit Q&A now available, with several examples on medical devices

Preparing for Brexit is not just a matter for EU and national authorities, but also for private parties. Businesses are reminded of the legal repercussions that need to be considered when the United Kingdom ceases to be a member of the EU.

This document analyses the impact of the UK's withdrawal on non-food and non-agricultural products placed on the EU27 market as from the withdrawal date, while these recently published questions and answers provide additional guidance for specific scenarios, including related to medical devices.

There is a section dedicated to Brexit in the webportal for medical devices. The UK government has also issued guidance on using the new UKCA mark after Brexit, in addition to guidance for regulating medical devices in the event of a no deal scenario.

Read more here.

MDCG endorses documents at February meeting

The Medical Devices Coordination Group (MDCG), which is composed of representatives from the national competent authorities and the European Commission, held a meeting in Brussels in February at which several documents were endorsed. These documents are available here.

Are you a top medical expert and want to make a difference for patients with medical devices in Europe?

The Commission will publish an important call for clinical experts and experts in relevant scientific and technical areas later in 2019. Selected candidates will be appointed to expert panels as laid down in the new Regulations on medical devices and in vitro diagnostic devices. The panels have a broad spectrum of advisory roles to the Commission, the Medical Device Coordination Group, Member States, Notified Bodies and manufacturers. Expert panels will namely play a key role in improving pre-market assessment of high-risk medical devices.

More information how to apply will be provided on the European Commission's website on Medical Devices. Sign-up for the newsletter to receive information in real-time!

Stay tuned for future updates!

Further updates will follow soon – we will inform you when new resources become available.

A factsheet for healthcare professionals and health institutions is under preparation and should be available in the coming weeks.

The website allows also to give feedback on the information available. If you think documents or links are missing, please send us a feedback here. In case you would like to submit ideas to better inform the stakeholders please let us know by filling the same feedback form..