EU Commission New Rules For Auditing by NBs

The EU Commission published “Commission Recommendation of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices.”

This clarifies and strengthens the criteria for certifying (and auditing) notified bodies, and the criteria that the notified bodies have to use in assessing companies and products.

The main changes are that the member states are required to do a joint assessment of a potential notified body with experts from the Commission and then they must carry out surveillance and monitoring of notified bodies. It also requires notified bodies to do unannounced factory audits which they were not allowed to do before (but the FDA does these).

The recommendation states, “As publication of residual risks in the information given to the user does not reduce the risk, but publication of residual risks and warnings used as risk control measure may be beneficial, have residual risks been correctly placed on IFUs or provided in training, and have manufacturers evaluated whether those warnings are effective…” This clarifies that although labeling cannot reduce risk, labeling can still be used as a risk control measure.

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