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EU Authorised Representative (EU REP)

The EU Authorised Representative Service Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union. For manufacturers of medical devices who fall into the above category, it is … Read more

Concept of MDR Medical Device Regulation.

EU Medical Device Regulation

The EU Medical Device Regulation 2017/745 (MDR) entered into force on 26 May 2017 and began to apply from 26 May 2021, superseding the EU Medical Device Directive 93/42/EEC (MDD) and the Active Implantable Medical Device Directive 90/385/EEC (AIMDD). Although there are many similarities between the two legislation, the MDR presents a key update for … Read more

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