The Medical Device Coordination Group (MDCG) regularly publishes very helpful documents that help notified bodies, authorities and manufacturers to correctly interpret the requirements of the Medical Device Regulation (MDR) We hereby report on new Guidance Documents.
Information has been published on the following topics:
Borderline and Classification
- MDCG 2022-5: Guidance on the distinction between medical devices and medicinal products in accordance with Regulation (EU) 2017/745 on medical devices (April 2022) The guideline discusses the various approaches to categorisation and comes to the following conclusion:
Die Bestimmung der Art der Substanz in Frage, d. h. ob sie „als Arzneimittel gilt“, ist unabhängig von der Absicht des Herstellers, von der Menge der Substanz im Produkt und von der Art oder dem Weg der Verabreichung. Auch die Feststellung, ob die Substanz „eine ergänzende Wirkung zu derjenigen des Produkts hat“, ist wissenschaftlich objektiv und hängt nicht von der Absicht des Herstellers hinsichtlich der Wirkung dieses Stoffes in dem Produkt ab. Bei der Feststellung, ob die Substanz eine „ergänzende Wirkung zu dem Produkt“ hat, sollte die Verfügbarkeit der Substanz für den menschlichen Körper oder seine Bestandteile und/oder die Menge, die für den menschlichen Körper oder seine Bestandteile verfügbar ist, berücksichtigt werden. Es obliegt dem Hersteller nachzuweisen, ob die Substanz eine zusätzliche Wirkung zu der des Produkts hat oder nicht, und zwar auf der Grundlage des Stands der Wissenschaft. Eine einfache Behauptung würde nicht ausreichen.
Clinical investigation and evaluation
- MDCG 2019-9-Rev 1: Summary of Safety and Clinical Performance (SSCP) (March 2022)
The SSCP (Summary of Safety and Clinical Performance) is intended to provide the public with access to an updated summary of the clinical data and other information on the safety and clinical performance of the medical device. The SSCP will be an important source of information for the intended users - both healthcare professionals and, where relevant, patients. The guideline describes in detail the background and purpose of individual aspects of the SSCP. Finally, examples of implementation are given.
Notified bodies
- MDCG 2022-4: Guidance on surveillance in relation to the transitional provisions under Article 120 of the MDR in relation to devices certified under the MDD or the AIMDD (February 2022)
This guidance document describes appropriate activities to be carried out by Notified Bodies in the context of surveillance under the MDR. In order to clarify the elements to be verified by the notified bodies, this guide also contains requirements for certain obligations of manufacturers, in particular with regard to their quality management system.
Unique Device Identifier (UDI)
- MDCG 2022-7: Questions and answers on the UDI system in accordance with Regulation (EU) 2017/745 and Regulation (EU) (May 2022)
This guide discusses / answers typical questions about the UDI. It provides (non-exhaustive) practical assistance for implementing the UDI requirements. It is a helpful tool in everyday regulatory work, especially when dealing with this relatively new and unfinished database.
Other topics
- MDCG 2022-11MDCG position paper: Advice to manufacturers to ensure timely compliance with MDR requirements (June 2022) This document emphasises that, from the MDCG's point of view, a large amount of guidance has been provided on the implementation of the MDR. All manufacturers making use of the transition period until 2024 should, in order to ensure that their products can continue to be placed on the market and to avoid bottlenecks, adapt their System and prepare for the transition to the MDR. and finalise the transition to the MDR. They should register with a Notified Body and submit complete and compliant applications as soon as possible and in good time before the end of the transition period to ensure timely compliance with the MDR requirements. In other words; there is no prospect of a further transition period.
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