Checklist: MDR compliance is more than obtaining a CE mark

For medical device manufacturers, MDR compliance depends on a continuous compliance process covering the entire product lifecycle.

A compliant setup must include:

•        Manufacturer responsibilities and an effective QMS

•        General Safety and Performance Requirements under Annex I

•        Risk management according to ISO 14971

•        Clinical evidence, literature review and gap analysis

•        Clinical evaluation and the Clinical Evaluation Report

•        Complete and continuously updated technical documentation

•        Post Market Surveillance, PMCF and

•        Vigilance activities

The key point:

MDR compliance does not end once the device enters the market.

Clinical evidence, risk management and post market data must remain aligned throughout the full lifecycle. This is in many cases heavily underestimated by medical device manufacturers.

GSI-CERT supports medical device manufacturers in establishing, reviewing and maintaining the structures required for sustainable EU market access.

Which area currently creates the greatest challenge for your organisation:

•        clinical evaluation,

•        technical documentation,

•        risk management or

•        post market surveillance?

Find out more info on our homepage here