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New medical device regulation

Future changes for Medical Devices

new medical device regulation

In June 2016 European lawmakers and regulators have published the draft of a new Medical Device Regulations. Once final approval is achieved the new MDR will replace the current Medical Device Directive 93/42/EEC and the Directive on Active Implantable Medical Devices 90/385/EEC.

The draft of MDR mentions several key points that are differ from current Directives for medical devices and active implantable devices. The most important suggested changes include:

  • Product scope extension (Annex XV): the scope of MDR will include devices that may not have medical intended purpose such as colored contact lenses and cosmetic implant devices and materials;
  • Clinical evidence requirements: the manufacturers shall specify and justify the level of clinical evidence necessary to demonstrate compliance with the relevant essential requirements on safety and performance (Annex I), which shall be appropriate to the characteristics of the device and its intended purpose. Manufacturer may rely on equivalent products only under very strict conditions;
  • Labelling changes (Annex V, Part C): Unique Device Identification (UDI) must be assigned to all medical devices itself or its package. Higher level of packaging shall have their own UDI. This requirement is expected to increase the ability of manufacturers and Authorities to trace specific devices through the supply chain, and to facilitate the prompt and efficient recall of medical devices that have been found to present a safety risk;
  • European Authorized Representative: European Authorized Representatives will continue to liaise between national Competent Authorities and foreign manufacturers who do not have a physical presence in Europe for getting their CE certification. The major change is that the European Authorized Representative will also be held liable along with the foreign manufacturer, for any defect found in a device manufactured by it and sold in Europe;
  • Notified Body: Strengthening the Notified Bodies is another of the major changes suggested by the new MDR regulation. As a result, Notified Bodies, which EU Member States designate to evaluate if a product that is planned to be placed on the European market satisfies a set quality and regulatory standards, will become more surveillance-oriented rather than being consultative that they are right now;
  • CE Marking: Certificates issued prior to final implementation of the MDR in late 2019 or early 2020 will have a maximum validity of five years. However, all CE Mark certifications issued before implementation of the new regulations will automatically expire four years after the new regulations come into force (by 2024).

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