GMP for Medical Devices

The aim of the course is to identify similarities and differences between the regulations of the FDA and the European regulations for Medical Devices. The focus will be on

A Notified Bodies representative will start the course by explaining the regulatory requirements, especially regarding the new EU Medical Device Regulations

Since 1996, the requirements for the development, the manufacture and the distribution of medical devices in the USA have been laid down in the revised cGMP regulations for Medical Devices (21 CFR 820, QSR). In the USA, medical devices are regulated by the FDA’s Center for Devices and Radiological Health (CDRH). Inspections  are primarily performed by the FDA.

 

In Europe, three EU directives (90/385/EWG, 93/42/EWG and 98/79/EG) and one amending directives regulate the medical devices industry. In May 2020, the new Medical Device Regulation will come into force. GMP regulations - strictly speaking - are not notified.

Instead, harmonised standards, especially ISO 13485, represent the state-of-the-art in the area of the EU. Inspections are primarily performed by Notified Bodies („New Approach for Product Regulations and Conformity Assessment“).

 

With the revision of the ISO 13485 in 2016 there are also new (“GMP”-) requirements.

 

Statistical data about deficiencies of medical devices do only exist in the USA because of the Freedom of Information Act. For years now, CAPA/Complaint Handling, insufficient Design Controls, Management Responsibility, Process Controls and Process Validation and Quality Audits have been among the Top 10 deviations.