GMP for Medical Devices

Name: GMP for Medical Devices
Start: 2020-10-13
End: 2020-10-13
Location: GMP for Medical Devices

13/14 October 2020

Heidelberg, Germany

Course No 17539

Our Service

Costs

ECA-Member:	EUR 1490,--
Non ECA Member:	EUR 1690,--
EU/GMP Inspectorates:	EUR 845,--
APIC Member Discount:	EUR 1590,--

(All prices excl. VAT)

Registration

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

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

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

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

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. 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.

Target Group

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.

Programme

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

3 Parallel Workshops concentrating on technical documentation, classification and submission and audit findings, will provide practical orientation:

Documentation: 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.

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