Legal requirements of the EU Regulation for medical devices
To be able to bring medical devices to market, the EU Regulation for Medical Devices / Medical Device Regulation (MDR) sets out a clear, yet very complex, pathway.
In our MDR basic course, you will learn step by step which requirements you need to consider in order to bring your medical devices to market according to the MDR. Each step is clearly explained and illustrated with many practical examples.
The seminar contents
- Medical device introduction
- The path to CE marking
- Start phase
- Intended purpose, legal regulation / guidelines, classification, conformity assessment procedure, person responsible (PRRC)
- DEVELOPMENT PHASE
- Technical documentation, essential requirements, harmonized standards, UDI, EUDAMED, clinical evaluation / clinical investigation
- RELEASE-PHASE
- EU Declaration of Conformity, CE marking, Registration in the medical devices register, Medical Devices Operator Ordinance ,
- POST-MARKET-PHASE
- Post Market Surveillance, Vigilance, Post Market Clinical Follow-up, Modification of the medical device
Costs
1-day in-house training: €3,890 (excl. VAT) for up to 10 participants
Includes seminar materials and certificate of participation; travel expenses additional
your trainer
DI Martin Schmid, General manager & Senior-Consultant at en.co.tec
Information about our trainers
Book now:
Please send your request to seminare@encotec.at or call us: +43 1 8863491 +43 1 8863491
