The Medical Devices Introductory Course 2020

What PMCF is not

• Intended to replace the pre-market data necessary to demonstrate conformity with the provisions of the legislation • A substitute for generating clinical data, when required, during the pre-market phase • An opportunity to explore use of the device in new patient groups or for new indications not within the scope of the intended purpose for which it has been CE-marked • A post-market clinical investigation, user report, survey or other form of proactive data generation that has been designed for purposes other than: • Confirming long-term safety and performance

• Monitoring residual risks • Detecting emerging risks

The Organisation for Professionals in Regulatory Affairs

What PMCF is not - caveat

• Data accepted under the current MDD may no longer be accepted under the new MDR • ‘Grandfather’ devices no longer acceptable • Challenges will include clinical data generated for CE-marking that no longer complies with the requirements of the MDR (e.g. those not compliant with the current version of the Helsinki Declaration or EN ISO 14155:2011) • A practical solution may be to undertake PMCF to generate additional clinical data to support safety and performance and address identified gaps for these types of devices

The Organisation for Professionals in Regulatory Affairs