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PMS Planning and Challenges under EU MDR

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?

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