In Part II of II, you will learn more about the demands in the requirements profile of the person responsible for regulatory compliance (PRRC – MDR Article 15-3c and 3d) in the context of post market surveillance and vigilance. Mr. Stok will illustrate these requirements in a practical way, by referring the MDCG guidance papers.

The seminar is aimed at all employees of medical device manufacturers from risk class I as well as manufacturers of Custom Made Devices. We do not recommend any specific prior knowledge, but the following prior knowledge is advantageous:

• Accompanying activity at a medical device manufacturer or EC-REP
• Experience as a safety officer for medical devices in accordance with the old MPG
• Experience as a QM representative or RA or TD manager at the manufacturer
• (Internal) auditor or consultant for medical device manufacturers or EC-REP

• Market surveillance (PMS/PMCF)
• Vigilance according to Article 88 and Article 89
• Manufacturer Incident Report (MIR-Form) and EUDAMED
• Notification deadlines and terms incl. Medical Devices User Notification

Participant discount: From the 2nd participant you will receive a discount of 15% and from the 5th.

Customer discount: mdc customers receive a 10% discount on the net price.

Participant and customer discounts cannot be combined!

Please note that the registration fee and the associated participation only applies to one person. If several people take part in the seminar (remotely) even though only one person has registered, we reserve the right to exclude them from the seminar.

450.00 Euro (plus value added tax)