4611092-EN

Medical Device Regulation (MDR) in Detail - English

Instructor-led Training1 dayBeginnerPräsenztraining

All manufacturers of Class I to III medical products must familiarize themselves with the requirements of the Medical Device Regulation (EU) 2017/745 (MDR) as soon as possible. The regulation has far-reaching implications and affects all classes of medical products. Products that are not medical products as such are regulated by the Medical Device Regulation (MDR). Among the aspects changed are the classification of products, previous basic requirements, technical documentation, clinical evidence, market surveillance, and quality management systems. The European approval process is uniformly regulated and entails significant changes in terms of organization goals. The scrutiny procedure, reprocessing requirements, and the introduction of the European database Eudamed also bring about profound changes. In our one-day seminar, you will gain a compact overview to align your company with the requirements of the Medical Device Regulation (MDR).

Details | Détails

Contents and Fundamentals of the Medical Device Regulation (MDR)
Classification/Reclassification of Products
Non-Medical Products within the Scope of the Medical Device Regulation (MDR)
Common Technical Specifications
New Basic Requirements
Content Requirements for Technical Documentation
Post Market Surveillance
Scrutiny Procedure
Validity of Conformity Assessment and Certification, Transition Periods
Requirements for Different Actors, e. g.:
- Manufacturers
- Importers
- EU Representatives
- Distributors and Service Partners
Role of Person Responsible für Regulatory Compliance (PRRC)
Eudamed Database
UDI (Unique Device Identification)

Vorteile | Benefits | Avantages

The legal requirements of the Medical Device Regulation (MDR) will be provided to you in a compact form.
You will receive an overview of the efficient and safe manufacture of medical products in accordance with the Medical Device Regulation (MDR).
You will gain an understanding of your responsibilities and obligations as a manufacturer, EU representatives, importers and distributers of medical devices Class I to III.

Teilnehmerkreis | Who should attend | Public principal

Newcomers in the medical device industry
Expert and executive personnel to update their knowledge
Personnel in charge of regulatory affairs
Personnel in quality management
Consultants in the medical device industry

FAQs

As a participant, you will receive an edition of the pocketbock Medical Device Regulation (MDR).
This seminar is offered as a basic module of modular further education. After successful participation in the advanced modules, you can obtain the recognized degree as MDR-Expert TÜV.

Durchführende Akademie | Executing Academy | Académie organisatrice

Dieses Onlinetraining wird von der TÜV SÜD Akademie GmbHin Deutschland durchgeführt. Bei diesem Onlinetraining gelten daher die AllgemeinenGeschäftsbedingungen und Prüfungsordnungen sowie Datenschutzinformationen der TÜV SÜD Akademie GmbH. Bei Rückfragen stehenwir Ihnen gerne zur Verfügung.

This training is being operated by TÜV SÜD Akademie GmbHin Germany. The GeneralTerms and Conditions as well as the PrivacyNotice of TÜV SÜD Akademie GmbH apply. Incase of any questions, do not hesitate to contact us.