In the course of the transition from MDD 93/42/EEC to the new MDR 2017/745, the old MEDDEV documents that applied under the MDD are gradually being replaced by MDCG guidance documents under the MDR and IVDR. Although these guidance documents are not legally binding, they are advised to be considered and implemented.
Importance of the guidances
The MDCG Guidances, which address the implementation of the new European Medical Devices Regulation, are not legally binding, but their application is generally expected. They implement Article 105 of the MDR, in which they are intended to contribute, among other things, to the "effective and harmonised implementation of the Regulation".
Tasks of the MDCG
The Medical Device Coordination Group was established by the MDR in the first place. It consists of at least one and at most two experts from each Member State and at most two alternates, all of whom are experts in the field of medical devices and in vitro diagnostic medical devices, appointed for a period of three years.
In addition to providing guidance on the harmonised implementation of the MDR, the Coordination Group is also involved in the monitoring of technical progress, the further development of norms and standards and the assessment of Notified Bodies, and assists competent authorities in a wide range of regulatory areas. It shall also serve as a contact point for the Commission when it comes to details of the functioning of the Notified Bodies Coordination Group referred to in Article 49.
The influence of the coordination group on the implementation of the regulation should therefore in no way be underestimated.
Which guidances are currently used?
Currently, there are still some MEDDEV guidances, but also more and more MDCG guidances that are applied. In particular, new topics such as UDI and the EUDAMED database are only addressed by the MDCG guidances.
Last year, the MDCG published many new guidances, so that the MEDDEV guidances have already been replaced in most areas. In 2020 a total number of 28 guidances was added.
Particularly much has happened in the areas of Clinical Investigation and Evaluation, Notified Bodies and Commission Guidance documents. In
detail, the following were added in 2020:
Clinical Investigation and Evaluation:
In the MDR, the scope and weighting of the clinical evaluation are significantly expanded compared to the MDD. Whereas 2019 there was only one guidance document on clinical evaluation and testing, the MEDDEV documents are now increasingly being replaced or supplemented at this point. In 2020, seven more documents were published to help manufacturers.
- MDCG 2020-5 Guidance on clinical evaluation - Equivalence
- MDCG 2020-6 Guidance on sufficient clinical evidence for legacy devices
- MDCG 2020-7 Guidance on PMCF plan template
- MDCG 2020-8 Guidance on PMCF evaluation report template
- MDCG 2019-9 Summary of safety and clinical performance
- MDCG 2020-10/1 Appendix: Clinical investigation summary safety report form
- MDCG 2020-10/2 Guidance on safety reporting in clinical investigations
- MDCG 2020-13 Clinical evaluation assessment report template
We have already taken a first look at the first two Guidances in two separate blog articles, which go into detail on the recommendations for action contained therein:
MDCG 2020-6 "Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC" identifies recommended actions to facilitate the identification of clinical data to demonstrate conformity with the MDR's essential safety and performance requirements, which are required as part of the technical documentation for medical devices already on the market. The article Data of established medical devices in further use looks at this guidance in depth.
MDCG 2020-5 "Clinical Evaluation - Equivalence: A guide for manufacturers and notified bodies" provides guidance on equivalence considerations for medical devices. The document is dedicated to the differences between MDR and MEDDEV 2.7/1 Rev.4, which are mainly reflected in the evaluation criteria for equivalence in technical, biological and clinical characteristics. This guidance was also discussed by our experts in the article
Assistance in the equivalence assessment of medical devices.
Many documents in the Notified Bodies sub-category had already been published in 2019. In 2020, these were supplemented by six more guidance documents dealing with, among other things, MDSAP Audit Reports (MDCG 2020-14) and exemptions in relation to audits of Notified Bodies during the COVID 19 (MDCG 2020-4) pandemic. All new guidance documents at a glance:
- MDCG 2020-3
Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD
- MDCG 2020-4
Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions
- MDCG 2020-11
Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation (EU) 920/2013
- MDCG 2020-12
Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissues
- MDCG 2020-14
Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR)
In the area of New Technologies, the increasing importance of software was taken into account, so that in the year before last, the two Guidances
- MDCG 2019-16 rev.1 –
Guidance on cybersecurity for medical devices und
- MDCG 2019-11–
Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746
were published. In 2020, a guidance on the clinical evaluation of medical device software followed:
- MDCG 2020-1
Guidance on clinical evaluation (MDR)/Performance evaluation (IVDR) of medical device software
There is also news on the topic of UDI. Updated general guidance on UDI for systems and treatment units (MDCG 2018-1 v3) and on UDI-DI and related changes (MDCG 2018-3 Rev1) were published. In addition, specific guidance for visual aids was issued at the end of the year:
- MDCG 2018-3 Rev.1
Guidance on basic UDI-DI and changes to UDI-DI
- MDCG 2018-1 v3
Guidance on UDI for systems and procedure packs
- MDCG 2020-18 Rev 1
MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers
On 01.12.2020, the first module of the EUDAMED database, theActorRegistration Module, went online. Prior to the activation of the Actor Registration Module, a position paper of the MDCG on the use of this database module and the Single Registration Number (SRN) generated with it was made available to familiarise oneself with the module:
- MDCG 2020-15
MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States
EMDN (European Medical Device Nomenclature)
The European Medical Device Nomenclature (EMDN) introduces a European nomenclature to be used by manufacturers when registering their medical devices in EUDAMED. The Italian nomenclature "Classificazione Nazionale Dispositivi medici" (CND) serves as the basis for the structure of the EMDN. Details on the principles and background of CND and EMDN can be found here:
- The CND nomenclature - Background and general principles
- The EMDN - The nomenclature of use in EUDAMED
Commission guidance documents
A central and all-defining theme of 2020 was the COVID 19 pandemic, which also had a significant impact on the medical device industry. In light of this current situation, a number of useful guidance documents were published by the Commission during the year, addressing the areas of medical face masks, personal protective equipment (PPE), in vitro diagnostic medical devices (IVDR) and 3D printing, which were in particularly high demand in the COVID 19 context:
- Conformity assessment procedures for protective equipment
- Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-1
- Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context
- Guidance on regulatory requirements for medical face masks
- How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used - also in the COVID-19 context
According to an overview list of the MDCG (as of December2020), a number of further publications are planned for the new year, especially in the area of market surveillance, on the topic of standardisation in the area of medical devices and on Notified Bodies - some of which were originally still planned for 2020. So it is worth keeping your eyes and ears open for the new guidance documents and the replacement of the MEDDEV documents.
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.