PMS Planning and Challenges under EU MDR
Post Market Surveillance, as described in the EU MDR Medical Device Regulation, is a new concept. A manufacturer shall know at all times how his product performs in the field. For each device, the manufacturer shall establish a post-market surveillance system (PMS system) which should be the integral part of the manufacturer’s QMS and shall be based on a post-market surveillance plan (PMS plan). Mainly, the PMS system shall be a proactive process and shall be constantly updated.
Topics covered in this Comprehensive Guide include:
- What are the requirements of the post-market surveillance plan?
- What are the documented procedures referenced for the PMS plan?
- What are the PMS Challenges under new EU MDR?