The European Parliament called for a revision to the existing medical directives and associated legal framework to guarantee the safety of medical technology. Therefore, the EU Medical Devices Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD)) will be replaced by a new Medical Device Regulation (MDR). This has significant impact on some classifications, conformity assessment, safety & performance requirements and clinical evidence.
The PIP breast implants fraud case not only showed a lack of transparency, but it led to a decrease of public trust in the system and CE-marking. Thus, with the new MDR, an extended database on medical devices providing more information on the quality and safety of devices on the market will be available. Another improvement is the introduction of Unique Device Identification (UDI) codes to enhance post-market safety, to reduce medical errors and to fight against counterfeiting. Additionally, manufacturers of implantable devices are to provide an implant card, allowing the identification of the implant and giving information about it. Also, several devices that were beforehand classified as IIb are classified as class III now. This includes, among others, most implants and certain devices incorporating nanomaterial. This means that a technical documentation review and product certificates are necessary.
The requirements regarding clinical evidence have been taken from existing standards (ISO 14155) and guidance (MedDev 2.7.1) and included in the Regulation. The MDR requirements in the post-market phase for clinical follow-up are taken from MedDev 2.12-2. Additionally the regulation applies the general rule that class III and implantable devices should be evaluated on the basis of clinical investigation data.
The MDR changes the oversight of Notified Bodies (NB). Whereas with the MDD control and monitoring was largely on a national approach, with the MDR control is down to member states and the Commission.
It also has an effect on the NB’s Sown quality systems. The MDD had one page of requirements for Notified Bodies. Regulation 920/2013 increased these significantly. Annex VI of the proposed MDR has 33 pages of detailed requirements for Notified Bodies.
Requirements for unannounced audits described in Recommendation 473/2013 have also been included in the regulations.
Annex VI includes requirements for physical, laboratory or other tests have to be carried out by NBs in the context of sample checks, assessment of the technical documentation and type examination. These tests will have to be completed by appropriate laboratories. Testing may be to harmonized standards or to common specifications in the future.
The new regulations are based on the same principles as the directives, there are many areas that have been strengthened: more rigorous designation and oversight of Notified Bodies, clearer incident reporting and coordination between national surveillance authorities, expanded traceability, UDI and implant cards and expanded requirements for clinical evidence.
"From the point of view of a test laboratory, the MDR does not require new evidence for the product standards", emphasizes Stefan Hofmann – Team Lead Medical and Head of Laboratory at CSA Group Europe GmbH. "And although the harmonized standards are known from the MDD, the 'common specification' still is a new conception, also for the test laboratories, we do not know if the Commission will harmonise the standards against the Regulations.
The alliance between CSA Group, a world leading medical device testing and certification organization and BSI, one of the leading Notified Bodies in Europe, brings together an unrivaled mix of expertise, enabling manufacturers to create and bring their medical devices to patients and healthcare professionals all over the world, fast and predictably.
CSA Group and BSI understand that speed and certainty about project deadlines is paramount when accessing global markets. They have therefore have built a global strategic alliance to provide a one-stop service that guides electro-medical device manufacturers through the key stages of market access: Product Testing according to IEC 60601; CE-Marking incl. Technical File Review; Quality Management System Assessment according to ISO 13485.