Notified bodies and medical device manufacturers are facing many challenges in the transitional period to the full applicability of the new Medical Device and In Vitro Diagnostics Regulations (MDR and IVDR, respectively).
On the one hand, Notified bodies have to undertake a re-designation process to be able to keep certifying medical devices under the new Regulations, and some started applying for this already in November 2017. Whereas it is uncertain how many of them will be successful at it, and whether they will keep the same scope or not, a recent press release from The European Association for Medical Devices of Notified Bodies informs that the 20 members integrating the so-called “Team NB” have already applied for designation, whereby half of them have applied for a wider scope (Survey on NBs applications against new regulations).
On the other hand, Notified Bodies have encouraged manufacturers to start dialoguing in order to become ready for the upcoming challenges. In this sense, the Competent Authorities for medical Devices (CAMD) has recently published two FAQs documents that should help manufacturers navigate in the complexity of the transitional period (FAQ – MDR Transitional provisions and FAQ – IVDR Transitional provisions). One of the critical challenges under the new Regulation will be to demonstrate compliance with the applicable General and Safety Performance Requirements (GSPRs), both for already marketed as well as for new medical devices. In this sense it is interesting to note that the Good Regulatory Review Practices Working Group of the International Medical Device Regulators Forum (IMDRF) is currently working on a new guideline that reflects most of the text on GSPRs from both MDR and IVDR, thus bringing this relevant aspect of the new EU Regulations to international standard for medical devices globally (Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices).
Asphalion closely follows news and movements from key stakeholders around the new MDR and IVDR to better assess manufacturers on their implementation.
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