GMP for Medical Devices EU versus USA

GMP for Medical Devices

Munich, Germany

Seminar Nr. 19530



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Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail:


Dr Gerhard Bauer, Bauer-Lewenz Consulting
Harald Rentschler, mdc medical device certification GmbH
Dr Heinrich Prinz, PDM-Consulting
Jesper Wagner, NIRAS


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
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 directive used to regulate the medical devices industry. In May 2020 however, the new Medical Device Regulation came 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“).
The revision of the ISO 13485 in 2016 also came with new (“GMP”-) requirements.
Statistical data about deficiencies of medical devices 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.


This event has been especially designed for the manufacturers who are subject to the medical device legislation and want to become familiar with the practice-oriented implementation of the legal requirements in the USA and in Europe.

3 Parallel Workshops

concentrating on technical documentation, classification and submission and audit findings, will provide practical orientation:
How to structure a technical documentation.
Classification and Submission of Medical Devices in the USA
How to classify and submit Medical Devices in the USA?
Preparing for an Audit according to the New European MDR
For two examples of medical devices relevant sections of the new European MDR will be analysed in order to identify the main audit items, which contain new or enhanced requirements.


Overview about similarities/differences between Medicinal Products and Medical Devices
  • Regulatory Submission
  • Guidelines
  • Supervision
Certification Procedure under the European MDR
  • Economic Operators
  • Classification of medical devices
  • Selection of certification procedure
  • Certification by Notified Bodies
Differences between EU and FDA Requirements
  • European Requirements
  • FDA Requirements
  • Differences and common interests
Classification and Premarket Submission of Medical Devices in the USA
  • Classification rules in the USA
  • IDE
  • 510k, PMA
  • De novo, HDE
GMP-Related Requirments of EN ISO 13485:2016
  • Role of ISO 13485:2016
  • Documented procedure
  • Key requirements
Technical Documentation vs. DHF/DMR
  • Content of Technical Documentation
  • Technical Documentation as a linking document between production and quality control
  • Change Management – Retests
  • Content of the DHF
  • Relation to the DMR
  • Link to Technical Documentation
  • Audit and inspection findings
Combination Products
  • The Guidance for Industry and FDA Current Good Manufacturing Practice for Combination Products – an overview
  • Combination products in the EU – Guidelines and Definitions
  • How to classify the combination product
  • Conformity assessment
  • The consultation procedure
Design Controls
  • Introduction of regulatory requirements
  • Common aspects/differences regarding the requirements of the ISO 13485 and 21 CFR 820
  • How to implement Design Controls in the whole life cycle process
  • Modern concepts of development of products
  • Audit and inspection findings
Qualification and Validation
  • Regulatory requirements (FDA, Standards, GHTF)
  • Risk assessments
  • Qualification
  • Validation
  • Audit and inspection findings
Regulatory Audits under MDR and MDSAP
  • Purpose of the MDSAP
  • DSAP Audtiting Organizatons
  • Focus point on regulatory audits
  • Unannounced audits by Notified Bodies
CAPA/Complaint Handling
  • Regulatory requirements (EU, FDA, Standards, GHTF)
  • Common aspects/differences regarding the requirements of the ISO 13485 and 21 CFR 820
  • New ISO 13485:2016 requirements
  • CAPA – the motor for continuous improvement
  • Monitoring as a Subsystem
  • Interface complaint handling /CAPA System
  • Audit and inspection findings


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