“Toto…We’re Not in Brussels Anymore”. Accounting for National Legislation on the Yellow Brick Road to CE marking

By Ed Ball – Manager, Intelligence

In our recent series of blogs on CE marking and medical devices in the EU, we have considered EU legislation beyond the EU MDR and IVDR ^{1, 2}, we have explored Europe and the EU ³, and we have highlighted the benefits of a CE mark outside of the EU ⁴. In this blog we will discuss one more aspect; one that is often overlooked…national legislation.

Once upon a time, medical device regulatory affairs folks were very familiar with national legislation in Europe. The three medical device directives (AIMDD, MDD and IVDD) all required transposing into national legislation to actually become laws. With the switch to EU regulations and the publication of the EU MDR and IVDR, national legislation has often taken a back seat in the wider discussions about regulatory requirements for CE marking. But does it still have a place? Is it still important? This blog will highlight six areas where national legislation plays an important role in the implementation of the MDR and IVDR.

Languages

Now we all know the first official languages of the EU, don’t we? No prizes for guessing that it wasn’t English.

Anyone that is responsible for labelling and instructions for use content, or translations will be able to tell you (hopefully) that there are 24 official languages in the EU (ranging from Bulgarian to Swedish) ⁵. Then there are those official languages of other countries for which the EU MDR and IVD apply, such as Icelandic, Norwegian, and Turkish. The MDR Article 10(11) and the IVDR Article 10(10) both require the information set out in Annex I (i.e. the GSPRs) to be available in “an official Union language as determined by the Member State”. The IVDR then has the same requirement for the information provided with IVDs for self-testing or near-patient testing, with the addition that the information must be “easily understandable”. This opens the door for the logical consideration that not all users are the same, and thus their language requirements may differ.

The Member States are not obliged to legally specify the languages(s) to be used. Sensibly, to avoid any confusion in the implementation of this requirement, and then the assessment of conformity against this requirement, many Member States have published clear legislation or guidance on their official language(s) to be used as part of labelling and information for use. Some Member States have gone one step further and clarified that devices intended solely for use by healthcare professionals can be provided in one language (e.g. English) whilst devices intended for use by non-professionals must be provided in at least one of the native languages of that Member State. Keeping track of all that can be a challenge. Thankfully, the European Commission have published reference documents for the MDR and IVDR ⁶, detailing all of the national provisions where Member States have opted for legally defining the language requirements for medical device manufacturers. This covers not just the labelling, instructions for use and the implant card, but also the Declaration of Conformity, Technical Documentation and Field Safety Notices (See examples in Figure 1).

A word of warning though…the languages specified by the Member States are the bare minimum. Depending on your target markets and intended user groups and patient populations, there may be languages spoken by a small but not insignificant population. From a risk management and usability perspective, this should be considered in addition to the baseline regulatory requirement.

Clinical Investigations & Performance Studies

The requirements for clinical investigations and performance studies include authorisation by the Member State(s) in which the investigation/study will take place, and an ethical review in accordance with national law (MDR Art 62 and Annex XV; IVDR Art 58 and Annex XIV). Given the complexity of clinical investigation submissions, it makes sense for Member States to provide some structure here. Just like with the language requirements, many member states have laid down legislation prescribing the authorisation requirements for clinical investigations and performance studies ^7-11. Other Member States prefer to keep this as guidance rather than legislation, which allows it to be more dynamic and updated more easily as and when necessary ¹².

Reprocessing of Single-Use Devices

“Reprocessing and further use of single-use devices may only take place where permitted by national law and only in accordance with this Article.”

MDR 2017/745 Article 17 (1)

That’s nice and clear. The reprocessing of single-use devices needs to be permitted by national law in a specific Member State before any of the subsequent MDR requirements in Article 17 are considered. For those organisations involved with reprocessing single-use devices (and those manufacturers with single-use devices who know or suspect that their devices are being reprocessed), this could be a complicated situation to keep track of. It is, but the Commission do make it slightly easier by providing a whole section of their website devoted to reprocessing of single-use devices ¹³. Member States are obliged to inform the Commission of their national provisions on this subject, and the Commission then share that information. Thus, we know that the many Member States do not authorise reprocessing of single-use devices on their territory (See Figure 2). For those Member States that do authorise reprocessing of single-use devices, we are provided with a summary of which parts of Article 17 are permitted, not permitted and restricted; plus links to the national legislation also.

Custom-Made Devices

The EU MDR contains various requirements relating to custom made devices (e.g. Article 2 (3), Article 21, Article 52 (8), Annex XIII), as well as correcting my favourite typo from the MDD 93/42/EEC (Essential Requirement 13.3 g if you never spotted it). A key principle of a custom-made device is that it is made specifically in accordance with a written prescription to meet the needs of a specific patient ¹⁴. The person issuing the prescription must be authorised by national law on the basis of their professional qualifications etc. The prescribing individual does not necessarily have to be a healthcare professional ¹⁵ as long as they are authorised to prescribe by the applicable national legislation in each Member State. For manufacturers of custom-made devices operating across multiple Member States, it becomes critical to understand, in each Member State, who is authorised to prescribe, and equally what they are authorised to prescribe (e.g. it may not be appropriate for a dentist to prescribe an ankle-foot orthosis).

The New Kid on the Block

Regulation (EU) 2024/1860 introduced Article 10a to the EU MDR and IVDR regarding the notification of interruptions in the supply of medical devices and the discontinuation of medical devices. Whilst the text of Article 10a does not strictly rely upon national laws for implementation, it is similar to the vigilance system until such time that EUDAMED is operational. By that, it is meant that the legal requirement involves a notification to the competent authority of the Member State where the device manufacturer, or its authorised representative, is established. Each competent authority must then establish, and communicate, how they wish to receive these notifications. Some have established elements of this in national law ^{16, 17}, whilst others have simply communicated this via their website ^18-20. The publication of the notification template ²¹ provides a consistent format for the notifications, and many competent authorities have set-up specific email addresses to receive the notifications (See Figure 3). As well as communicating the notification to the other affected competent authorities (as per Article 10a (2)), it is assumed that each competent authority then has their own process for how to manage such a notification in their own territory depending on the structure of their healthcare system.

And Last but Not Least

If the above discussion of a select few requirements tied to national legislation is giving you a headache, or worse, then spare a thought for your friendly notified body reviewers. As part of the MDR and IVDR requirements for notified body competence (Annex VII), notified bodies must verify that their personnel are aware of “Union and national law in force on devices”. That should mean… for all Member States. Sounds delightful! Rest assured, they will probably be verifying the same aspect of competence thing during conformity assessments of device manufacturers.

Summary

The purpose of this blog was not to scare anyone, but to highlight the role that national legislation plays in the CE marking process with several examples provided. The EU MDR and IVDR are the main focus of course, but there are many horizontal EU regulations and more pieces of national legislation that we need to be mindful of when establishing our regulatory strategies, our design and development plans, our quality management system processes and our post-market surveillance processes ²².

Related next steps

If you’re having difficulty navigating the EU regulatory landscape and struggling to comply with horizontal EU regulations, our experts specialise in helping manufacturers develop comprehensive regulatory strategies designed to ensure that medical devices and IVDs comply with all applicable EU legislation.

Contact us to discuss how we can support your efforts and stay tuned for more updates related to the European Medical Device landscape in our upcoming blog posts.

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1. Recent Developments in EU Horizontal Legislation
2. Medical Devices, IVDs and Other EU Laws
3. Europe, the EU, and the EU Single Market: geopolitical implications for MedTech
4. Where can your CE mark take you next?
5. Languages (European Union)
6. Overview of language requirements for manufacturers of medical devices
7. S.I. No. 261 of 2021 Medical Devices Regulations 2021
8. Ordonnance n° 2022-582 du 20 avril 2022 portant adaptation du droit français au règlement (UE) 2017/745 du Parlement européen et du Conseil du 5 avril 2017 relatif aux dispositifs médicaux
9. Décret n° 2024-795 du 8 juillet 2024 relatif aux investigations cliniques et aux études des performances
10. Act of 24 October 2019, containing rules on the safety and quality of medical devices (Medical Devices Act)
11. Royal decree implementing the law of 22 December 2020 on medical devices
12. Danish Medicines Agency – Clinical investigation of medical devices
13. National rules on reprocessing of single-use devices
14. Custom-made devices
15. MDCG 2021-3 – Questions and Answers on Custom-made devices & considerations on adaptable medical devices and Patient-matched medical devices
16. Law on the implementation of EU provisions concerning medical devices (Medical Devices Law Implementation Act – MPDG) Section 7a Procedure for the obligation to provide information pursuant to Article 10a of Regulation (EU) 2017/745 and Article 10a of Regulation (EU) 2017/746
17. BfArM – Notification of interruptions or discontinuations of the supply of a medical device
18. ANSM – Report a discontinuation or discontinuation of a medical device or in vitro diagnostic medical device
19. FAMHP – Obligation for manufacturers to notify interruptions or discontinuations in the supply of medical devices and in vitro diagnostic medical devices
20. MHRA – Notification of interruption or discontinuation of the supply of a medical device for manufacturers based in Northern Ireland
21. MDCG 2024 – 16 Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices (as per Article 10a of Regulation (EU) 2024/1860 amending Regulation (EU) 2017/745 and Regulation (EU) 2017/746)
22. Enhancing Competitiveness in MedTech: Smart Strategies with Regulatory Intelligence

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