New medical devices regulation: EU reaches deal
ADDE considers the agreement on the EU medical device regulation a good compromise. With the new rules, the European level of safety in medicine and dentistry will be raised to a higher standard. However, the regulation could jeopardise existing relationships between producers and distributors, if manufacturers are not able to meet the required quality and safety standards. Dental dealers would then be forced to work with other producers, which could have an impact on pricing and products.
The agreed regulations are expected to achieve a twofold aim: ensuring that medical devices and in vitro diagnostic medical devices are safe, while allowing patients to benefit from innovative health care solutions in a timely manner.
The main elements include the following:
- Tightened rules for the designation of notified bodies and for the monitoring of their activities by relevant national authorities
- Extra provisions on producers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market
- Strengthened rules on clinical investigation seeking to increase the availability of reliable clinical data on medical devices
- The requirement for producers and importers of devices to register themselves and their products on a central EU database
- The setting-up of an EU portal where serious incidents and corrective actions by manufacturers will be reported—devices will have a unique identification number to provide for traceability throughout the supply chain to the end-user or patient.
Certain high-risk devices, such as implants, may undergo an additional check by experts before they are placed on the market. Expert panels and laboratories will play a key role in supporting the legislative system, to provide expertise and guidance on clinical aspects to notified bodies, competent authorities and manufacturers. Furthermore, the new EU rules explicitly cover certain devices without a medical purpose, but with similar characteristics to those of medical devices. Examples are fillers and coloured contact lenses for cosmetic purposes.
The next steps
On 15 June 2016, the Council of the European Union’s Permanent Representatives Committee endorsed the agreement reached with the European Parliament. The European Commission stated that it too supported the agreement reached between the two co-legislators. Since the agreement has been confirmed by the European Parliament’s ENVI Committee, the council will approve the agreement at minister level. This is planned for September, once the draft regulations have been translated into all official languages. After their legal-linguistic revision, the new regulations will have to be approved by the council and the European Parliament. They will apply three years after publication as regards medical devices and five years after publication as regards in vitro diagnostic medical devices.
Please have a look at the official website of the European Council for more information.