MDCG – Medical Device Coordination Group is a new entity that has been introduced with the EU Medical Device Regulation 2017/745 and In-vitro Diagnostic Regulation 2017/746.
The MDCG takes part to a lot of different processes within the EU Medical Device Landscape and it is well known for having the responsibilities to to prepare specific guidelines to support the implementation of the EU MDR and IVDR. Inn fact, we all know the challenges that this regulation brings to the medical device sector, for example in relation to clinical evaluation and investigation, preparation of the technical documentation, post-market surveillance, etc.
In this article we will discuss the role of MDCG – Medical Device Coordination Group in relation to the requirements specified in the MDR, with a brief overview of the most important guidelines that have been developed so far.
Medical Device Coordination Group and Article 103
The regulation related to Medical Device Coordination Group is documented within article 103 of EU MDR.
Section 2 fo Article 103 defines the composition of MDCG. Specifically, each member state is allowed to appoint, for a 3-year term, one member and one alternate with expertise in the field of medical device, and one member and one alternate with expertise in the field of in vitro diagnostic medical devices.
These members are representative of the competent authorities of the member states and thus shall be selected based on their knowledge and expertise in the field of medical devices and IVD.
Section 3 of Articles 103 specifies that MDCG shall meet at regular intervals and upon specific request by the Commission of by a Member State. It is important to mention that agenda and the related minutes of meeting of the MDCG are publicly available and published on the website of European Commission. For example, in this page it is possible to find the minutes of one of these meeting.
What are the tasks of the Medical Device Coordination Group
The tasks of the MDCG – Medical Device Coordination Group are described within Article 105 of the EU MDR 2017/745 and article 99 of the EU IVDR 2017/746.
Specifically the tasks mentioned within Article 105 EU MDR are:
- to contribute to the assessment of applicant conformity assessment bodies and notified bodies pursuant to the provisions set out in Chapter IV;
- to advise the Commission, at its request, in matters concerning the coordination group of notified bodies as established pursuant to Article 49;
- to contribute to the development of guidance aimed at ensuring effective and harmonised implementation of this Regulation, in particular regarding the designation and monitoring of notified bodies, application of the general safety and performance requirements and conduct of clinical evaluations and investigations by manufacturers, assessment by notified bodies and vigilance activities;
- to contribute to the continuous monitoring of technical progress and assessment of whether the general safety and performance requirements laid down in this Regulation and Regulation (EU) 2017/746 are adequate to ensure safety and performance of devices, and thereby contribute to identifying whether there is a need to amend Annex I to this Regulation;
- to contribute to the development of device standards, of CS and of scientific guidelines, including product specific guidelines, on clinical investigation of certain devices in particular implantable devices and class III devices;
- to assist the competent authorities of the Member States in their coordination activities in particular in the fields of classification and the determination of the regulatory status of devices, clinical investigations, vigilance and market surveillance including the development and maintenance of a framework for a European market surveillance programme with the objective of achieving efficiency and harmonisation of market surveillance in the Union, in accordance with Article 93;
- to provide advice, either on its own initiative or at request of the Commission, in the assessment of any issue related to the implementation of this Regulation;
- to contribute to harmonised administrative practice with regard to devices in the Member States.
As you can see, the responsibilities of the MDCG are quite broad; however the most important tasks are related to the development of specific guidelines for MDR implementation and contribution of the conformity assessment of notified bodies in relation of their MDR notifications.
Overview of MDCG Guidelines
Currently there are already plenty of MDCG guidelines that have been published to support the implementation of the European Medical Device Regulation.
For the moment, MDCG guidelines have been developed covering the following topics:
- Borderline and Classification
- Clinical Investigation and Evaluation
- COVID-19
- Custom-Made Devices
- Eudamed
- European Medical Device Nomenclature
- Implant Cards
- In-Vitro Diagnostic Medical Devices
- New Technologies
- Notified Bodies
- Standards
- Unique Device Identifier.
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