Technical File consulting and audit

Technical File consulting and audit

Technical File consulting and audit

From 26 May 2020, new devices will have to meet the requirements of the MDR in order to be placed in the European market. Devices holding a certificate from a European notified body under either the Medical Device Directive (93/42/EEC) or the Active Implantable Medical Devices Directive (90/385/EEC) have an additional grace period and may continue to be placed on the market until 26 May 2024 if the manufacturer fulfils the specific prerequisite requirements drawn in the MDR.

Some of the key changes include:

Product scope expansion. The definition of medical devices and active implantable medical devices will be significantly expanded to include devices that do not have a medical intended purpose.

Reclassification of devices according to risk, contact duration and invasiveness. The MDR will require device manufacturers to review the updated classification rules and update their technical documentation accordingly by considering the fact that class III and implantable devices will have higher clinical requirements and a regular scrutiny process.

More rigorous clinical evidence for class III and implantable medical devicesManufacturers will need to conduct clinical investigations in case they do not have sufficient clinical data to support the claims made on both safety and performance of a dedicated device.

Systematic clinical evaluation of Class IIa and Class IIb medical devicesManufacturers will need to re-prepare their clinical evaluation by considering the new wording of the regulation on when an equivalence approach and under which circumstances it is possible to justify not conducting a clinical investigation.

More stringent documentation. 

Identification of ‘person responsible for regulatory compliance’