More regulatory oversight for medical devices comes into force

Increased regulatory oversight of Notified Bodies (NBs) came into force this week (15 October), delegates were told at the TOPRA Annual Medical Devices Symposium held in Lisbon, in conjunction with the Portuguese Agency Infarmed.

The changes have been prompted by a number of concerns, particularly regarding the recent public health issues surrounding defective PIP breast implants. In February 2012 a joint plan to improve the functioning of NBs was published. This led to a Commission Implementing Regulation on the designation and supervision of NBs [(EU) No 920/2013].

Dr Rainer Edelhäuser, Director of ZLG, Germany and Chair of NBOG (Notified Body Operations Group), Germany, outlined the changes which will have a significant impact on all NBs – and sponsors. For example, mandatory joint assessments are now required by a team of auditors comprising two assessors from Designated Authorities (DAs) from another Member State than the NB and a Commission representative. If the NB loses the right for a type of product, then the sponsor will need to transfer its product to another NB, Dr Edelhäuser explained.

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