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With the EU-MDR, a new term has found its way: economic operator. This does not only include manufacturers. Agents, importers and dealers are also explicitly named. If trade was not specifically mentioned in Directive 93/42/EEC, the EU-MDR now makes clear specifications. Economic actors are required to handle the medical devices they have at their disposal with care and to comply with the control and information obligations. The seminar conveys the regulatory basics and practical aspects that go hand in hand.
topic overview
- New definition of the term manufacturer
- Entry into force, start of validity and transitional periods
- Requirements for economic operators
- Tasks of the national authorities
- Technical documentation at the authorized representative
- (Re)labelling, storage, repackaging and translation of documents
- Reporting obligations and market observation
- contract constellations
target group
Representatives of dealers, importers, agents and manufacturers.
previous knowledge
Not mandatory.
KONTAKT:
Online
