New EU Rules on Medical Devices
There are over 500,000 types of medical devices and in-vitro diagnostic medical devices on the EU market. Examples of medical devices are contact lenses, x-ray machines, pacemakers, breast implants, hip replacements and sticking plasters. In vitro diagnostic medical devices, which are used to perform tests on samples, include HIV blood tests, pregnancy tests and blood sugar monitoring systems
The existing regulatory framework dates back to the 1990s and consists of three directives. However, problems with divergences in the interpretation and application of the rules, technological progress as well as incidents involving malfunctions of medical devices–e.g. the PIP breast implant scandal—highlighted the need for revision of current legislation. The European Commission is also currently working on more structural and horizontal solutions for better market surveillance.
The EU Parliament recently adopted the proposal for the Medical Device Regulation, which will replace the current Medical Device Directive (93/42/EEC) and Active Implantable Medical Device Directive (90/385/EEC). The final text will be published in the Official Journal of the European Union in May.
The new regulations on medical and in-vitro diagnostic medical devices will help to ensure that all medical devices—from heart valves to sticking plasters to artificial hips–are safe and perform well. To address this, the new rules will improve market surveillance and traceability as well as make sure that all medical and in vitro diagnostic devices are designed to reflect the latest scientific and state-of the-art technologies. The rules will also provide more transparency and legal certainty for producers, manufacturers and importers and help to strengthen international competitiveness and innovation in this strategic sector.
The vote on April 5, 2017 to approve the new regulations bring several improvements for medical and in-vitro devices, including:
- Improve the quality, safety and reliability of medical devices: The new rules will impose tighter controls on high-risk devices such as implants, requiring a pool of experts at the EU level to be consulted before placing the device on the market. Controls will also be tightened on clinical trials as well as on the bodies that can approve the marketing of medical devices. The new rules will also cover certain, previously unregulated aesthetic products (e.g. colored contact lenses that do not correct vision). In addition, a new system for risk classification in line with international guidelines will apply to in-vitro diagnostic medical devices.
- Strengthen transparency of information for consumers: The new regulations will make sure that vital information is easy to find. For instance, patients will receive an implant card with all the essential information, and a unique device identifier will be mandatory for every product so that it can be found in the new European database of medical devices (EUDAMED).
- Enhance vigilance and market surveillance: Once devices are available for use on the market, manufacturers will be obliged to collect performance data and EU countries will coordinate more closely in the field of market surveillance.
To allow manufacturers and authorities to adapt, the new rules will only apply after a transitional period, namely three years after publication for the regulation on medical devices and five years after publication for the regulation on in vitro diagnostic medical devices.
More Information and Resources
Now that the new regulations have been approved, many medical device companies have begun mapping out how their business will be impacted. Regulatory consulting firm Emergo has identified 10 common industry questions and concerns regarding the new regulation. Read “Top 10 European MDR Questions.”
For the European Commission’s collection of resources about the new MDRs, including a fact sheet, FAQ, and an industry overview, visit the following links.
Contact Welocalize Life Sciences for information on how we can help medical device manufactures with translation of CE Marks, IFUs and other regulated materials.