MDCG Guidance Documents – Guidance documents for every topic

MDCG Guidance Documents

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 have been gradually replaced by MDCG guidance documents and form the new guidance foundation under the MDR and IVDR. Although these guidance documents are not legally binding, the general advice is prevalent that they should be considered and implemented.

The MDCG, its mission and importance

The Medical Device Coordination Group is established by the MDR in the first place. It consists of at least one, at most two experts from each Member State and at most 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 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. It also assists competent authorities in a wide range of regulatory areas and also serves as a focal point for the Commission when it comes to details for the functioning of the Notified Bodies Coordination Group under Article 49. This shows that the influence of the MDCG on the implementation of the Regulation should in no way be underestimated.

Thus, the MDCG documents assist manufacturers, authorities, Notified Bodies and other stakeholders in the consistent interpretation and application of the requirements of the Regulations and sometimes also provide concrete examples and guidance. As the MDCG Guides are prepared by MDCG Expert Working Groups and subsequently approved by the European Commission and the Joint Coordination Group, they always represent the common interpretation of the requirements of the Regulations by the authorities of the Member States. For this reason, a high level of importance can be attributed to them.

What topics are covered by the MDCG guides?

Gradually, more and more MDCG guides are being established. These are divided into different topic areas, which can be found on the overview page of the European Commission Public Health. In the following, we would like to dive deeper into each topic area and show the important aspects, the scope and any special features.

In recent years, the range of topics has developed considerably compared to the guides available in the past. The focus is no longer on a single guide, but on the entire topic concerned. In 2020 alone, for example, a whole 28 new guides were added, so that even in the early phase of the transition from MDD to MDR, many MEDDEV guides could be replaced. Especially in the areas of Clinical Investigation and Evaluation, Notified Bodies and Commission Guidance Documents, a lot has happened. Accordingly, some topics are dealt with in greater detail than others, depending on how the relevance of the respective topic is rated.

1. Borderline and Classification

Whether a device can be classified as a medical device or not always depends on the intended purpose of the product. In most cases, a classification is unambiguous, but there are certainly products that are in between a medical device and a medicinal product or even combine elements of both. For these products, it is then necessary to clarify which requirements (may) apply and how they should be considered from a regulatory point of view. The MDR already regulates this situation and the distinction in Article 1, paragraphs 8 and 9 on the subject of “combination products“. However, the MDCG 2022-5 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices provides detailed guidance on this topic and detailed criteria and principles for deciding whether a product should be classified as a medical device or a medicinal product. Thus, this guidance in particular is essential for manufacturers, Notified Bodies, Competent Authorities and other stakeholders to ensure that devices are appropriately classified and regulated. In addition, manufacturers are encouraged to contact competent authorities and seek advice early in the development process if there is uncertainty about the classification of their product.

2. Class I Devices

This topic area currently consists of only two guidance documents, which provide brief instructions for manufacturers of Class I devices, especially for the transition phase from the MDD to the MDR. Even if Class I devices are not certified by a Notified Body, they must of course also fulfil the applicable requirements. Thus, especially during the transition period to the MDR, the guides were a good point of reference for any questions regarding the implementation of the regulations and remain relevant for Class I manufacturers.

3. Clinical investigation and evaluation

Since the scope and emphasis of the clinical evaluation has become significantly more important in the MDR – compared to the MDD – the need for guidance documents on this topic is particularly high.

Two of the first guidelines in particular are relatively groundbreaking. These are MDCG 2020-6 “Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/38/EEC” and MDCG 2020-5 “Clinical Evaluation – Equivalence: A guide for manufacturers and notified bodies”. The first guide provides recommendations to facilitate the identification of clinical data to demonstrate compliance with the essential safety and performance requirements of the MDR. Clinical data are essential, as they are required as part of the technical documentation for medical devices already on the market. In one of our articles, we show how to deal with data of established medical devices in further use, following the specifications of this MDCG guide .

Another important aspect is the equivalence assessment of medical devices. MDCG 2020-5 provides assistance in this regard. The document is dedicated to the differences between MDR and MEDDEV 2-7/1 Rev. 4, which are particularly evident in the assessment criteria for equivalence in technical, biological and clinical characteristics. Particularly in the transition phase, guidance on equivalence assessment of medical devices in detail is an important step .

In addition, aspects such as the post-market clinical follow-up (PMCF) plan and report, safety reporting and support for sufficient evidence for legacy devices are considered in more detail in this topic area. Thus, the sum of the guidelines can also be used to provide concrete guidance on collecting clinical data, conducting systematic literature reviews and evaluating clinical data from different sources. In this way, the MDCG emphasises the importance of providing solid clinical evidence for the safety and performance of medical devices. Last but not least, a Commission Guidance (2023/C 163/06) “on the content and structure of the summary of the clinical investigation report” was published in May 2023, which specifies the exact bullet points of the report and a format that is designed to be simple and understandable for the end user. However, it does not go beyond the tabular requirements already listed in the MDR.

4. COVID-19

Especially in the initial phase of the pandemic in 2020, several guidance documents were published. The topics addressed in these guides are mainly the “Regulatory requirements for ventilators and related accessories” (MDCG 2020-9) or other requirements for medical face masks, in vitro diagnostics and personal protective equipment – topics that were highly relevant at the beginning of the pandemic. Furthermore, 3D printing also played a crucial role in addressing certain challenges during the pandemic. For example, regulatory and quality control considerations had to be quickly established to ensure the safety and efficacy of 3D-printed medical products or equipment. 3D printing became so important because of its overall flexibility and ability to respond quickly to urgent needs such as disrupted supply chains, assisting in the production of personal protective equipment or bridging supply shortages. In particular, the guidance on “Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19” provided good support. As the pandemic progressed, guidance was published in 2021 for manufacturers of in vitro diagnostics to regulate the handling of mutated versions of the virus and to ensure the safety and efficacy of the products in this new environment (MDCG 2021-7 and MDCG 2021-21 Rev. 1).

5. Custom-Made Devices

The MDCG 2021-3 guide is in a simple Q&A format to provide specific information on custom-made devices, which are also specifically defined in it. This allows manufacturers to get directly to the information they are looking for and also provides concrete examples.

6. EUDAMED

On 01.12.2020, the first module of the EUDAMED database, the Actor Registration Module, went online. Prior to the release of the Actor Registration Module, a MDCG position paper 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. Since then, two more guidance documents have been published, one for medical devices (MDCG 2021-1 Rev. 1) and one for in vitro diagnostic medical devices (MDCG-2022-12), describing how to proceed under a harmonised management technique and alternative technical solutions until EUDAMED will be fully operational.

It is well known that not only manufacturers have to be registered in EUDAMED, but also other economic operators, although in the past there has always been a lack of clarity. The MDCG 2021-13 Rev. 1 “Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR” addresses this.

Currently, no further guidelines are planned for EUDAMED, but it remains to be seen how it will develop further after EUDAMED has received its full functionality and all modules have been activated.

7. European Medical Device Nomenclature (EMDN)

The European Medical Device Nomenclature 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

A separate FAQ document (MDCG 2021-12) explains the most important aspects of the EMDN to support the use of EUDAMED. Thus, the nomenclature is particularly relevant for manufacturers when registering their product in the database as well as when assigning the UDI-DI. In addition, the EMDN also plays an important role in the technical documentation associated with the product, as it also supports, among other things, the main description of the product and can be a sampling criterion. It is important not to confuse the EMDN with the GMDN (Global Medical Device Nomenclature), which is still relevant outside of Europe. There is no correlation between the given number ranges.

8. Implant cards

Article 18 of the MDR deals with requirements for manufacturers of implantable medical devices. Manufacturers must provide information with such a device that enables identification of the device, including the device name, serial and lot number, UDI, device model and the name and address of the manufacturer. MDCG 2019-8 v2 “Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices” and MDCG 2021-11 “Guidance on Implant Card – Device types” provide specific assistance in implementing these requirements of the MDR.

9. In-house devices

Medical devices can be manufactured and used on a non-industrial scale within EU healthcare facilities (in-house devices) to meet the specific needs of certain patient groups that cannot be met at the appropriate level of performance by an equivalent CE-marked device available on the market. Accordingly, many requirements of the MDR or IVDR do not apply to in-house devices. Nevertheless, there are some aspects in Article 5(5) which must be complied with in order to ensure the highest level of safety and efficacy of such devices. MDCG 2023-1 “Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746” provides concrete guidance on this.

10. Authorised Representatives, Importers, Distributors

As certain requirements apply only or specifically to importers , distributors or Authorised Representatives, there are also separate guidance documents for these actors to assist with implementation. The MDCG 2021-26 deals in particular with repackaging and relabelling of products – “Q&A on repackaging and relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746”.

However, in the introduction to the guide, the MDCG itself points out that the information is not considered complete and should always be read in conjunction with the MDR and other possible requirements. Nevertheless, one receives a very practical guide to implementing the obligations as a distributor, importer or authorised representative. In principle, these guides are of interest to any economic operator as part of contract negotiations.

11. In Vitro Diagnostic medical devices (IVD)

A very detailed topic area with a whole of 12 guides can be found for in-vitro diagnostics – and some are still in further planning. In principle, all important individual topics are covered. There are supporting documents on:

• Classification of IVDs based on risk, performance characteristics and intended use (MDCG 2020-16 Rev. 2),
• Information on conformity assessment procedures, including the involvement of Notified Bodies (MDCG 2021-22 rev. 1)
• Guidance on conducting performance evaluations and clinical performance studies to demonstrate the safety and performance of IVDs, as well as guidance on preparing and evaluating clinical evidence, including data collection, study design and clinical trials (MDCG 2022-2)
• Requirements for post-market surveillance activities, including vigilance reports and ongoing monitoring of IVDs on the market
• Information on how Notified Bodies assess IVDs for conformity with the IVDR requirements
• Guidance on the requirements for labelling and the content of instructions for use, as well as information on the implementation of UDI systems to improve traceability.
• Classification approaches and regulation of IVD software

Especially for the transitional phase, there are also some guidance documents that regulate the handling of legacy devices. MDCG 2021-4 “Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746” and 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”. The MDCG 2022-6 also regulates the issue of possible changes to the product during the transition phase.

12. New technologies

In the area of New Technologies, the increasing importance of software was taken into account, and the topic of cybersecurity to which in particular special emphasis is placed on. MDCG 2019-16 rev. 1 “Guidance on cybersecurity for medical devices” lays the foundations for dealing with this increasingly relevant topic. The relevance of this aspect increases in particular as the new MDR and IVDR aim to ensure that medical devices placed on the EU market are suitable for the new technological challenges related to cybersecurity risks. In this regard, new essential security requirements are set for all medical devices containing electronic programmable systems and software. This obliges manufacturers to design and manufacture their products according to the state of the art, taking into account the principles of risk management, including information security, as well as minimum requirements for IT security measures and protection against unauthorised access.

13. Notified bodies

Many documents were already available in this topic area in 2019 and 2020, and it represents another large, detailed topic block. It is essential to present guidelines and instructions for the activities and responsibilities of Notified Bodies, as they play a decisive role in the conformity assessment procedure of medical devices and IVDs. Thus, the documents of the Coordination Group cover a range of issues and provide guidance on how Notified Bodies should fulfil their role in accordance with the MDR and IVDR, but also what requirements are placed on Notified Bodies and how the designation process is constructed. It also helps to ensure consistency and harmonisation in the interpretation and application of the rules within the Member States.

New issues include the handling of MDSAP audit reports (MDCG 2020-14) or exemptions with regard to audits of notified bodies during the COVID-19 pandemic (MDCG 2020-17 and 2020-4). Since there is also a separate topic area for the latter, it is even more relevant that the actions of the Notified Bodies are also regulated.

Among the listing, there are also some NBOG papers, which are Best Practice Guides by the Notified Body Operations Group and are intended to help improve the overall performance of Notified Bodies.

14. Post-Market Surveillance and Vigilance (PMSV)

So far, the topic of post-market surveillance is rather covered sparsely with only two guidance documents. However, several more guidance documents are in the planning stage, because the MDR has also made this topic more relevant, and it is becoming an important element for medical devices of all classes. One important guideline deals with the Periodic Safety Update Report which is a central point in the PMS, MDCG 2022-21 “Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745”. For clarification of the approach to vigilance issues, there is a “Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices” MDCG-2023-3. The other documents will also focus on post-market surveillance in the context of IVDs, as well as providing a summary of the general requirements for PMS processes.

Establishing a common understanding of these terms and concepts is necessary for effective and harmonised implementation of the vigilance requirements of the MDR and post-marketing surveillance.

15. Standards

A short, but nevertheless important topic, which covers the various aspects related to standards in the field of medical devices to support the requirements set out in the current EU legislation. There is the “Guidance on standardisation for medical devices” MDCG 2021-5.

16. Unique Device Identifier (UDI)

A complex topic that has caused many question marks, especially in the transition phase to the MDR is the UDI system. That is why it is all the more important to have a number of different guides to understand the implementation in concrete terms. To start with, general but updated guides on UDI for systems and treatment units (MDCG 2018-1 v3) were published, as well as on UDI-DI and related changes (MDCG 2018-3 Rev1). Further specific guidance documents cover the product group of visual aids.

In addition to guides that generally show how the UDI system can be implemented (MDCG 2019-2, MDCG 2019-1 or MDCG 2022-7), there are also specific documents, for example, that describe the implementation of the UDI

system into the company’s quality management system (MDCG 2021-19). Thus, details on the application and practical implementation of the UDI requirements are also given here for each topic.

How do I now navigate correctly through all the guides?

The structuring of the entire guides into individual topic areas is a helpful point of orientation. This way, you can find the information you are looking for relatively quickly. However, it is important to note that for certain topics, information may also be available beyond a certain topic area, but may also be relevant to the personal situation. This is especially the case with IVD topics, where one should not only search in this explicit topic block, but also beyond. A lot of information that is relevant for IVD manufacturers can also be found in topic areas such as PMS or vigilance, which means that one also has to take a closer look at these in order to find out which relevant requirements are still present there.

Another example for clarification also concerns the Covid-19 topic. There is a separate topic area for this, but when it comes to audits by Notified Bodies during the pandemic or a pandemic-like situation, for example, research must be carried out in the topic field on Notified Bodies themselves.

Even in cases where the MDCG guidance documents are not fully appropriate for your product’s situation, a single guidance document can provide insight into the principles of interpretation of the regulations.

Legal status – am I obliged to follow the guidelines?

The MDCG Guidelines, which address the implementation of the new European Medical Device Regulation, are not legally binding. Furthermore, the MDCG Guidelines do not introduce any new requirements that are not already included in the Regulations, such as the MDR. However, their application is generally expected. Thus, among other things, application of the guidelines implements Article 105 of the MDR, in which they are supposed to contribute to an “effective and harmonised implementation of the Regulation”.

In addition, it may well be that individual Notified Bodies instruct compliance with the Guides, or at least strongly recommend it, which increases the relevance of the documents. In general, however, the aim is to reach a consensus that it is possible to apply duly justified solutions that ensure that the overall objective of the guide is met by the manufacturer.

Relevance of the linguistic level

In contrast to other documents, such as legal texts, the MDCG guidelines are only available in English. At first glance, this does not appear to be a major obstacle, but caution is still necessary.

When applying the guidelines, attention should always be paid to the terminology used. Although the meaning of individual terms is generally defined, a different nuance can quickly be added in a different context, as the example of the use of the terms “intended use” and “intended purpose” shows. When comparing the use of these terms in the English and German versions of the MDR, certain differences can be pointed out. These are not always fundamental differences, but it is advisable to look more closely and take note of them.

For this reason, it is important to be able to assess how certain terms are used within the MDCG guidelines and whether the meaning is equivalent to the use within the MDR. Subtle differences can make all the distinction. Therefore, one should question the possible applications of the terms and not use them blindly. In specific cases, own application possibilities can also be defined, whereby this should always be well documented.

Additional documents besides the MDCG

In addition to the MDCG guidance documents, there are also other guidance documents that can play an important role. For example, relevant material is available from NBOG, Team NB and guidance documents from the EU Commission (Commission guidance documents). In particular, the NBOG Best Practice Guides are endorsed by the MDCG and can sometimes appear in conjunction with the MDCG documents. Thus, they are often listed together with Commission guidance documents in the general listing of MDCG guides. In addition, relevant position papers of Team NB are also attached for certain topics. In this way, Team NB also actively promotes the transparency of Notified Bodies and at the same time promotes the continuous improvement and development of products.

During the COVID-19 pandemic, for example, a number of useful guides were published by the Commission addressing areas of the medical device industry that were in particularly high demand in the pandemic context, such as face masks, personal protective equipment (PPE), in vitro diagnostic (IVD) devices or 3D printing.

Outlook and further planning

Anyone who thinks that there are already enough MDCG guides, should take advice. In a listing of the MDCG as of March 2023, numerous guides are announced for the year 2023. Among them, there will be further additions in the areas of Notified Bodies Oversight (NBO), Post-Market Surveillance and Vigilance (PMSV) and In Vitro Diagnostic Medical Devices (IVD). In the latter area in particular, a number of guidance documents are already being developed. As with many plans, the dates given in the list of MDCG subgroups are of course only indicative and it remains to be seen when the work on these guidelines will be completed.

Nevertheless, many more contributions from the MDCG can be expected in the coming years, as well as updates to existing guides to incorporate further current developments.

If you would like to know which guidelines apply in your case and how to find your way through the multitude of different guidelines, please contact our experts at seleon gmbh for support. We will be happy to assist you in selecting relevant guidelines and correctly interpreting the requirements adapted to your medical device.