Market surveillance activities in Europe have intensified significantly following the PIP Action Plan developed by the EU in 2013. The additional and more stringent requirements of Notified Bodies (NBs) has led to some NBs terminating their involvement with medical devices, effectively rendering the associated EC certificates obsolete.
Affected medical device manufacturers have endured a period of uncertainty; it has been unclear whether the EC certificates would remain compliant from a regulatory perspective and whether such manufacturers would be permitted to place devices on the market for the first time under their affected certificates.
In October, the EU decided to grant manufacturers with affected certificates a “period of grace”. The Swiss Competent Authority, SwissMedic, has now also recognised the need for a transition period and has granted manufacturers 12 months to become recertified with another NB. Affected manufacturers will be required to send a written statement confirming that they meet the conditions within 4 weeks of the NB de-designation. Such companies will also need to provide evidence from their new NB that recertification has been initiated.
The de-designation of some NBs has obviously led to further increased workload for the remaining NBs. Regulis’ view is that whilst a 12-month transition period is manageable in theory, manufacturers must act now in order to ensure that they factor in the current workload/available resource of their new NB.
Please click here to read the Swiss Medic announcement.
Has your NB been de-designated? If you need support in sourcing a NB with the correct expertise for your device, contact the Medical Device team at Regulis who can provide impartial advice on the matter.