Essentials of European Medical Device Regulatory Affairs

In the Company Legal Manufacturer The natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party European Authorised Representative If LM is outside community • established in the Community • Contact for CA and NB in the Community instead of the manufacturer • IMPACT OF BREXIT where your AR lives.

Additional in the regulation • Person responsible for regulatory compliance

• importer obligations • distributor definitions

Module 3

• Legislation in Europe • Medical Device Directives • Legislation of combination products • Revision of the directives

• Guidelines (MEDDEVs) • Harmonised standards

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