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EU Corner: Proposal for a regulation on Medical Devices Directives – are we any closer to a deal?
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The long-awaited revision of the EU Medical Devices Directives (MDD) is still underway.
A European Commission proposal to revise the existing legal framework on medical devices was adopted two and half years ago, but discussions to reach a final agreement on the new texts are still ongoing.
In the best-case scenario, the new regulation will be adopted by the end of the year, with a minimum 3-year transition period meaning full application in 2018.
In the meantime, the Commission and Member States have agreed to a Joint Action Plan to temporarily remediate to the loopholes revealed by the PIP breast implants scandal, however, a long-term solution requires a thorough revision of the legal framework.
The new MDD will undoubtedly have an impact on the development of new medical devices, including orthopaedic implants.
What are the key elements of the revised MDD?
- the scope of the current EU rules on medical devices is extended, for instance to implants for aesthetic purposes;
- economic operators must be able to identify who supplied medical devices and to whom they were supplied; manufacturers must fit their products with a unique device identification to ensure traceability;
- manufacturers and importers of both categories of products must register themselves and the devices they place on the EU market in a central European database;
- patients who are implanted with a device must be given essential information on the implanted product, including any necessary warnings or precautions to be taken, for example on whether or not it is compatible with certain diagnostic devices or with scanners;
- an EU portal is created on which manufacturers must report serious incidents and corrective actions they have taken to reduce the risk of recurrence; and
- notified bodies get the right and duty to carry out unannounced factory inspections and to conduct physical or laboratory tests on medical devices.
Progress to reach an agreement on the new legislation has been hampered by Member States’ divergent views on surveillance of devices before/after their placing on the market, the reprocessing of single use devices, the functionality of Unique Device Identification System; devices for aesthetic purposes and those manufactured in-house.
The Latvian Presidency to the EU is currently leading discussions to reach a Council position by June 2015.
It will be important that all National Societies are well informed on the final legislation and how it will impact the introduction of implants to the EU market and their access to patients.
- info
- European Commission webpage on revision of the MDD