Medical devices law — new provisions concerning notified bodies

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By Wolfgang von Rehmann

The European Commission published on 24 September the Implementing Regulation (EU) No 920/2013 on the designation and the supervision of notified bodies under the Council Directive 90/385/EEC on active implantable medical devices and the Council Directive 93/42/EEC on medical devices. On the same day, the commission also published a recommendation on the audits and assessments performed by notified bodies in the field of medical devices.

The provisions proposed by the commission in its regulation target better supervision of the accreditation bodies, and in particular of the notified bodies to be monitored by them, in the pursuit of their activities, the standardisation of examination standards and an improved exchange of information between the competent agencies and authorities at both the national and EU level in consultation with the commission.

The commission also proposes recommendations to the notified bodies on performing conformity assessment procedures. The measures are intended to improve supervisory and safety standards in the examination and monitoring of medical devices. They are also meant to create the transparency required to further develop safety standards on the basis of the findings and experiences at the community level and to ensure EU-wide uniform implementation…

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