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MDR Master ClassUpdates on latest developments in the EU
The deadline for upgrading your contract to MDR has passed. Your options are:
- To place your MDD certified products on the EU market until the
- End of 2027 (high risk)
- End of 2028 (medium / low risk)
- To get a contract with an NB without the advantages of keeping MMD products on the market.
Have a question? We have the answer
Issues to be covered
Participants are welcome and encouraged to submit their own questions ahead of time and out lectuerers will do their best to integrate them into the course materials specified below.
- Day 1: Update on latest news from Brussels (Update on NB designations, latest MDCG guidances, EU Dashboard on certification status, impact amendment MDR/IVDR – Eudamed – notification requirements, any other latest developments) – Specific questions from participants
- Day 2: QMS and TD requirements: Article 10 + Annex IX vs EN ISO 13485; Technical dossier requirements; Labeling and language requirements; Discussion on findings made during audit and TD review; Role PRRC. Specific questions from participants
- Day 3: Clinical evaluation – CEP, CDP, CER – linkage to RM, SSCP
- Day 4: PMS – PSUR and PMCF+PMCFER – linkage to Clinical and RM
Who should attend
Specifically PRRCS will benefit from the information provided
This Master Class is not suitable for beginners, as it will not discuss the fundamentals of the MD
About The Lecturer
