The Medical Device Coordination Group (MDCG) has published the following updates:
|Guidance No||About the guidance|
|MDCG 2022-11||MDCG Position Paper: Notice to manufacturers to ensure timely|
compliance with MDR requirements
From 27 May 2024, the MDR will be fully applicable to all medical devices.
Manufacturers are responsible to ensure that their devices comply with the MDR as from the end of the transition period. From that date, medical devices not certified under the MDR will have no access to the EU market.
It should be noted that around 70% of AIMDD/MDD certificates will expire in 2024 (by 26 May 2024 at the latest). Manufacturers should take into consideration that it might not be possible that notified bodies designated under the MDR would be able to assess all corresponding files within the first months of 2024.
Derogation from the conformity assessment procedure in accordance with Article 59 of the MDR has been mentioned as a possible remedy in case transition from AIMDD/MDD to MDR is not completed in time. It is important to stress that derogations may be granted by competent authorities only if the use of the device concerned is in the interest of public health, patient safety or patient health. This mechanism should not be considered as a solution for cases of late application to a
notified body for conformity assessment or delays in the conformity assessment procedure. Economic grounds alone cannot justify a derogation under Article 59 MDR either.
Therefore and in order to ensure that devices can continue to be placed on the market and to avoid shortages of medical devices, it is essential that all
manufacturers adjust their system, finalise transition to the MDR and apply to a notified body, submitting complete and compliant applications, as soon as possible and well in advance of the end of the transition period to ensure timely compliance with the MDR.
|MDCG 2022-10||Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)|
This Q&A intends to clarify certain interfaces between the Regulation (EU) No 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). It was developed by clinical trials experts from Clinical Trials Facilitation and Coordination Group (CTFG) and in vitro diagnostics experts from the IVD sub-group of the Medical Device Coordination Group (MDCG) . It has been adopted by CTFG, the Clinical Trials Expert Group of the European Commission and endorsed by the MDCG.
Assays used in clinical trials may range from CE marked in vitro diagnostic medical devices (IVDs) to trial- or medicinal product-specific assays that are not always meant to be developed as IVDs. The need to clarify requirements for these assays lead to the Q&A and the concept of the “medical purpose of an assay in a clinical trial” as a specific setting.
The CTR created a new framework for the assessments of initial clinical trial applications and applications for substantial modifications. The assessment procedure under the CTR will be driven by strict timelines and will require close cooperation between Member States concerned in multi-country trials. The aim of this Q&A is to support these coordinated assessments by providing clarification on the regulatory status of assays performed on human samples used in the context of clinical trials as well as on the regulatory expectations toward the clinical trial sponsors. The overall aim is to support the conduct of clinical trials using diagnostic assays, including combined trials for the development of companion diagnostics (CDx).
|MDCG 2022-9||Summary of safety and performance Template|
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires that the manufacturer shall draw up a summary of safety and performance (SSP) for class C and D devices, other than devices for performance studies. The SSP shall be validated by a notified body (NB) and made available to the public via the European database on medical devices (Eudamed).
This Summary of Safety and Performance (SSP) is intended to provide public access to an up-to-date summary of the main aspects of the safety and performance of the device.
The SSP is not intended to replace the Instructions For Use as the main document to ensure the safe use of the device, nor is it intended to provide diagnostic or therapeutic suggestions to intended users.
|MDCG 2022-8||Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC|
Regulation (EU) 2022/1121 extended the transitional provisions of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), in particular its Article 110(3), in terms of scope and timing. Following the approach set out in the report of the MDCG ad hoc task-force on transitional provisions of Regulation (EU) 2017/745 on medical devices (MDR) published as MDCG 2021-25 , the present document provides guidance as regards the applicability of IVDR requirements to ‘legacy devices’ and ‘old’ devices. The annex contains a non-exhaustive table illustrating IVDR requirements applicable or not applicable to ‘legacy devices’.
|MDCG 2022- 7||Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746|
This document presents questions and answers on the Unique Device Identification system (UDI system) established under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The questions covered by the document aim to provide further detail to operators on the application and practical implementation of the UDI requirements.
|MDCG 2022-6||Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR|
This guidance document:
· is intended to provide clarification on the concept of significant changes in the design and intended purpose’ under IVDR Article 110(3). It concerns manufacturers of devices that are compliant with Directive 98/79/EC and that are placed on the market or put into service after 26 May 2022 during the transition period in accordance with Article 110(3) IVDR, irrespective of whether or not those devices required notified body involvement under the IVDD.
· does not elaborate on the process for manufacturers’ submission and notified bodies’ assessment of changes to the approved design7 or substantial changes to the approved quality system or the product-range covered8 that are part of the conformity assessment process and surveillance defined by the relevant notified body under the IVDD.
Article 110(3) of Regulation (EU) 2017/746 (IVDR), as amended by Regulation (EU) 2022/112 , states that under certain conditions the following devices may be placed on the market or put into service after the date of application of the IVDR, i.e. 26 May 2022, until the end of the different transition periods specified in Article 110(3) IVDR:
· devices which have a valid certificate issued by a notified body under the Directive 98/79/EC (IVDD), and
· devices for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with the IVDD and for which the conformity assessment procedure pursuant to the IVDR (contrary to the IVDD) requires the involvement of a notified body.
The conditions for the application of the transitional provisions in Article 110(3) IVDR are that the devices continue to comply with the IVDD and that there are no significant changes in the design or intended purpose of the device after the date of application of the IVDR. Therefore, it is important for manufacturers and notified bodies to have a clear understanding as to what changes to design or intended purpose would be considered ‘significant’ under Article 110(3) IVDR.
To the extent that devices subject to the transitional provisions in Article 110(3) IVDR are covered by certificates issued by a notified body in accordance with the IVDD, it is essential for IVDs to be placed on the market that those certificates remain valid following changes that are not significant with regard to design or intended purpose and that the required appropriate surveillance is carried out by the notified body that issued the certificate. Manufacturer and respective notified body should agree on the latter on a contractual basis.
|MDCG 2022-5||Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices|
The demarcation between the Regulation (EU) 2017/745 on medical devices (MDR) on the one hand and the Directive 2001/83/EC on the Community code relating to medicinal products for human use (MPD) on the other hand is crucial for the proper implementation of these sets of legislation and their correct interpretation and enforcement. Several provisions to establish the demarcation between the two legal frameworks have been laid down in the MDR and MPD. This document provides further explanations and examples clarifying these provisions in order to support the uniform application of the MDR across the EU. It has been elaborated by a working group including experts from Member States’ competent authorities, the Commission services, European Medicines Agency as well as a wide range of stakeholders, and has been endorsed by the Medical Device Coordination Group (MDCG) – the governance group on medical device competent authorities at EU level .
The document starts with the general discussion of the borderline between medical devices and medicinal products, including relevant definitions and examples. Separate chapters are dedicated to herbal products, substance-based devices and medical device and medicinal product combinations.
This guidance document may be revised to reflect up-to-date scientific and technical knowledge as well as the outcomes of the regulatory discussions within the MDCG Working Group on Borderline and Classification.