Health-EU newsletter 233 - Focus
Commission launches portal to ease transition to new Regulations on medical devices and in vitro diagnostic medical devices
Timo Pesonen, the new Director General of the European Commission's Directorate General for Internal Market, Industry, Entrepreneurship and SMEs (DG Grow), discusses the revamped Medical Devices section on the European Commission's website that was launched to help smooth the transition to two new Regulations on medical devices and in vitro diagnostic medical devices. The portal presents the new regulatory requirements in various sections targeted at impacted actors (manufacturers, importers, health institutions, authorities in non-EU countries and others).
First, what is the importance of medical devices from an EU perspective?
People sometimes think medical devices are just things like hip replacements and pacemakers, but the range of medical devices is quite broad, including everything from contact lenses to adhesive bandages, X-ray scanners and in vitro diagnostic medical devices. Many of these devices are essential to our health and quality of life as well as to the European economy, and we expect them to be safe and effective.
Why was it necessary to introduce new Regulations?
Since the EU’s rules on the safety and performance of medical devices were laid down in the late 1990s,there have been discrepancies in their interpretation across Europe. Issues have arisen in some categories of medical devices, for instance breast implants and metal-on-metal hip implants.
To reflect progress over the last 20 years, the EU has revised the legal framework. Two new Regulations – one on medical devices and the other on in vitro diagnostic medical devices – were adopted by the Council and the Parliament, and entered into force in May 2017. After a transitional period, the Medical Devices Regulation will fully apply as of 26 May 2020, and the In Vitro Diagnostic Medical Devices Regulation will fully apply from 26 May 2022.
What will be the benefit of having these new Regulations?
The new Regulations will improve the quality and safety of devices on the EU market by reinforcing the criteria for the designation of notified bodies and processes for their oversight, introducing stricter pre-market control of high-risk devices and strengthening post-market surveillance. They set up a completely new system of unique device identifiers, improving the identification and traceability of medical devices. It creates a system to uniquely identify medical devices along the supply chain.
The new Regulations will increase transparency. Summaries of safety and clinical performance for high risk medical devices will be publicly available via the European database on medical devices (EUDAMED). The database will include information on devices, economic operators, clinical research and post-market surveillance, will help regulatory authorities coordinate and exchange information, and will be used to report and track incidents.
What can users expect to find on the new portal?
The revamped website explains the main differences between the current Directives and the new Regulations. It highlights the timeline for the transition along with deadlines for implementation and also offers resources targeted at journalists interested in the medical devices industry.
Activities at EU level
European Commission –Internal Market, Industry, Entrepreneurship and SMEs
The portal presents the new regulatory requirements in various sections targeted at impacted actors (manufacturers, importers, health institutions, authorities in non-EU countries and others).
These factsheets provide the most important information concerning the new medical device Regulations for various target groups.
All of this information provided by the European Commission is free to use and share.
These Guidelines by the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) concern guidance on how to perform benefit-risk assessment of phthalates used in certain medical devices. Deadline for comments is 29 April 2019.