GMP for Medical Devices

Objectives

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

• Classification Rules and Submission in the USA
• Certification Procedures
• Technical Documentation vs Device History File and Device Master Record
• Combination Products
• Design Controls
• Validation / Qualification
• Regulatory Audits
• CAPA and Complaint Handling

Background

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. Soon 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 also new (“GMP”) requirements will come.

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.

Three add-ons for free

FDA Medical Device Warning Letter Navigator on USB Stick
This stick contains:
The Medical Device-associated FDA and GHTF Guidelines with regard to Quality as pdf files
EU Medical Device-Directives and MedDev Documents
All Medical Device-associated FDA Warning Letters since 2002.

You will also receive the document „Validation of Processes for Production and Service Provision (including Software) - Essential Requirements” developed by the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) – English translation. This 8 page document aims at reaching a common understanding of validation of processes, including validation of software among notified bodies, manufacturers and the competent authorities, and at defining uniform requirements on the validation of processes to be met by the manufacturers and on the auditing of these processes by notified bodies or certification authorities.

Change Control SOP:
All delegates receive an example of a Change Control SOP with a Change Control Flowchart and a Change Application Form.