Post-Market Surveillance Documentation

Regardless of your medical device’s status and how long it has been on the market, the requirements set out under Annex III of the MDR/IVDR clearly define manufacturer responsibilities.

Some issues found:

• A failure to create post-market surveillance (PMS) plans that comply with MDR/IVDR requirements.
• Not ensuring that Periodic Safety Update Reports (PSURs) are created in line with their reporting periods based on classification.

Post-market surveillance (PMS) is a critical component of medical device lifecycle management. It ensures that devices continue to meet safety and performance expectations throughout their lifespan.

MedDev Regulatory (MDR) Consulting can provide the expertise and support that you need with post-market surveillance. Our consultancy services are tailored to meet your needs at competitive and cost-effective rates.