Regulatory Focus™ > News Articles > European Commission Strengthens Oversight of CE-Marking Process

European Commission Strengthens Oversight of CE-Marking Process

Posted 26 September 2013 | By

The European Commission issued new rules on 24 September 2013 that establish a new EU process for designating and monitoring Notified Bodies, establishing the basis for withdrawing such a designation and clarifying the expertise required for Notified Body staff.  

According to the Commission Implementing Regulation, a Member State can designate a public or private third party organization as a Notified Body only after a 'joint assessment' of the candidate has been conducted with experts from the Commission as well as other Member States. 

After a Notified Body has been designated, the Member State must implement a surveillance and monitoring program of the third party organization to ensure compliance with the Commission Recommendation on audits and assessments.  Notified Bodies that do not conduct random unannounced inspections of device manufacturing facilities as required by the Commission Recommendation run the risk of having their designation withdrawn. 

Notified bodies are responsible for overseeing local manufacturers of medium and high-risk medical devices. A local audit or assessment decision by a Notified Body concerning a medical device manufacturer results in a CE mark for the device that allows marketing throughout the EU.  Currently there are about 80 Notified Bodies in the European Union.


Tags: EU

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