As part 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, consideration and implementation is advised.
Significance of the guidance documents
The MDCG guides, which address implementation of the new European Medical Devices Regulation, are not legally binding, but their use is generally expected. They implement Article 105 of the MDR, in which they are intended to contribute to, among other things, the “effective and harmonized 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 a maximum of two deputies, all of whom are experts in the field of medical devices and in vitro diagnostic medical devices and are appointed for a period of three years.
In addition to providing guidance for the harmonized 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. However, it also serves as a focal point for the Commission when it comes to details for the functioning of the Notified Body Coordination Group under Article 49.
The influence of the Coordination Group on the implementation of the Regulation should therefore not be underestimated.
Which guidance documents are currently used?
Currently, there are still some guidance documents of the MEDDEV and more and more guidance documents of the MDCG that are applied. Especially new topics like UDI and EUDAMED database are only addressed by the MDCG guides.
In the last year, the MDCG has published many new guides, so that the MEDDEV guides could already be replaced in most areas.
In 2020, a full 28 new guides were added …
Particularly much has happened in the areas of Clinical Investigation and Evaluation, Notified Bodies and Commission Guidance documents.
Specifically, 2020 saw the addition of:
Clinical Investigation and Evaluation:
In the MDR, the scope and weighting of clinical evaluation are significantly expanded compared to the MDD. While there was only a single guidance document on clinical evaluation and investigation in 2019, the MEDDEV documents are now being replaced or supplemented more and more at this point. In 2020, seven additional documents were published to provide guidance to 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, in which the recommendations for action contained therein are discussed in detail:
MDCG 2020-6 “Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC” highlights recommended actions to facilitate the identification of clinical data to demonstrate compliance 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 from Established Medical Devices in Continued 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 addresses 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 has also been reviewed by our experts in the article
Assistance in equivalence assessment of medical devices considered in detail.
Notified bodies
Already in 2019, many documents in the Notified Bodies subcategory had been published. In 2020, these were supplemented by six more guidance documents that address, among other things, MDSAP Audit Reports (MDCG 2020-14) and exemptions related to Notified Body audits during the COVID-19 (MDCG 2020-4) pandemic. An overview of all new guidance documents:
- 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)
- MDCG 2020-17
Questions and Answers related to MDCG 2020-4:
“Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions”
New Technologies
In the area of New Technologies, the increasing importance of software was taken into account, so that in the year before last, the two Guidelines
- MDCG 2019-16 rev.1 –
Guidance on cybersecurity for medical devices and
- MDCG 2019-11 –
Qualification and classification of software – Regulation (EU) 2017/745 and Regulation (EU) 2017/746
were published. This was followed in 2020 by guidance on clinical evaluation of medical device software:
- MDCG 2020-1
Guidance on clinical evaluation (MDR)/Performance evaluation (IVDR) of medical device software
UDI
There is also news on the topic of UDI. Updated general guidance documents 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 came out 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
EUDAMED
On 01.12.2020 the first module of the EUDAMED database, the Actor Registration Module, went online. Before the Actor Registration Module went live, an MDCG position paper on the use of this database module and the Single Registration Number (SRN) it generates was made available to help familiarize users 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 December 2020), a number of further publications are planned for the new year, especially in the area of market surveillance, on the topic of standardization in the area of medical devices and on Notified Bodies – some of which were originally still planned for 2020. So it’s worth keeping your eyes and ears open for the new guidance documents and the replacement of MEDDEV documents.
Please note that all information and lists do not claim to be complete, are without guarantee and are for information purposes only.
