Written by Thomas Andreae, PhD Published: 23 June 2022
European Medical Device Regulation – One Year Experience
On May 26, 2021, the European Union (EU) implemented REGULATION (EU) 2017/745, the “Medical Device Regulation,” or MDR. After its first year in existence, the medtech community’s initial concerns with the MDR’s requirements have now become a matter of increasing frustration for many, including those of us who are dedicated to advancing the clinical adoption of focused ultrasound. This commentary examines the current situation for EU medical devices and the MDR’s impact on focused ultrasound’s technological development.
The Focused Ultrasound Foundation is working with MedTech Europe to gain understanding and determine a path to possibly influence or educate the MDCG and the European Commission. Read on to learn how European focused ultrasound companies and other stakeholders may submit comments on this issue.
The medical device community had concerns before MDR was implemented. These concerns were primarily related to how the MDR raised the requirements for many aspects of the medical device regulatory process, especially its documentation mandates. Small- and mid-sized companies (SMEs), which make up the majority of the focused ultrasound industry, simply do not have the resources and specialized know-how that are required for this mandate. Additionally, the MDR raised the bar for clinical data across all product classifications, potentially leading to higher cost and longer time-to-market for new devices. Furthermore, the requirements are often unclear and leave room for interpretation, especially in combination with other changing legislation and directives for implementation in the EU member states. These issues are increasing the entry barrier to the medical device market in the EU, and these barriers hit startups and SMEs with limited resources the hardest.
As of today, many of the necessary prerequisites needed for the smooth implementation of the MDR are missing. There is no fully functional European medical device database (Eudamed). Various EU legal acts create confusion, standards are not MDR-harmonized, and (most importantly) there is a capacity shortage at the Notified Bodies (NBs). Unlike in the United States, where regulatory approvals are handled by the FDA as a central agency, in the European Union this is delegated to commercial auditing companies, collectively called Notified Bodies. Because the MDR also raised the bar for NBs, the number of NBs accredited under the MDR has so far been significantly lower than those accredited under the previous Medical Devices Directives. This shortage leads to long processing times for applications. Importantly, new companies that have not yet commissioned an NB are having difficulties finding one. There is a serious capacity issue with NBs.
Like the manufacturers, the NBs also struggle with the interpretation of the extensive and sometimes vague requirements of the MDR and its missing harmonized standards. The NBs each have their own interpretation of the requirements, which may lead to unequal treatment of manufacturers. These differences may become very significant and impactful when it comes to clinical evaluation and clinical data.
The MDR has increased the requirements for clinical data and significantly restricted the possibility of using clinical data from comparable (equivalent) devices. This means that new products need clinical data generated from a specially designed clinical trial. However, clinical trials in medical technology are (still) the exception. Therefore, there is often a lack of relevant expertise in many areas, both on the part of the manufacturer and on the part of the NBs. In this respect, it is not helping that the MDR remains unclear regarding the exact requirements for clinical data and the clinical evaluation. The NBs are unable to fill this void, leaving manufacturers in the dark about the need for a clinical trial, acceptable clinical endpoints, study design, or number of participants, just to name a few. The high cost and long timelines that come with a clinical trial make it challenging, especially for SMEs to handle such uncertainties. But this is also an opportunity! Since medical devices vary enormously in their level of novelty, technological sophistication, and level of risk, there is never a one-size-fits-all approach, and the MDR deliberately does not go into detail about clinical data. Article 61(1) of the MDR says: “The manufacturer shall specify and justify the level of clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements.” (The MDR provides for a consultation process for clinical evaluations of certain Class III and Class IIb devices, but this is not applicable to noninvasive focused ultrasound systems.)
To facilitate implementation and further development of the MDR, the EU Commission has established a Medical Device Coordination Group (MDCG). Along with other tasks, the MDCG issues guidance documents to help with interpretation and implementation of the MDR. Many of these MDCG guidance documents are already available and regularly used by the NBs. The large section on clinical investigation and evaluation (e.g., MDCG 2021-6 Q&A regarding clinical investigation) can be found online at: https://ec.europa.eu/health/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en.
However, the previous clinical evaluation guideline (MEDDEV 2.7/1 Rev. 4 – Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under DIRECTIVES 93/42/EEC and 90/385/EEC) has not yet been replaced by a corresponding MDCG guidance and is still partly used. Therefore, it is advisable to check the MDCG website for updates before embarking on a clinical trial. Important to note is that all MDCG guidance documents are marked as nonbinding, and unlike standards, MDCG guidelines are not harmonized and do not trigger any presumption of conformity. But they are currently the best available right now.
The Focused Ultrasound Foundation is working with MedTech Europe to gain understanding and determine a path to possibly influence or educate the MDCG and the European Commission. For input and more concrete actions, MedTech Europe recommends working with national industry organizations. Accordingly, the German and French medtech industry organizations Bundesverband Medizintechnologie (BVMed) and “Syndicat National de l’Industrie des Technologies Médicales” (SNITEM) started a joint initiative to address these issues on a European level and issued a press release.
The German Society for Biomedical Technology (DGBMT) and its Regulatory Affairs Committee has taken the initiative and drafted a new document titled, “MDR: Recommendations for Implementing the Requirements.” In the document, DGBMT recommends ensuring a Europe-wide uniform interpretation of the MDR requirements by the NBs and promoting the development of skills for clinical trials in SMEs and hospitals. These draft recommendations are available in German.
European focused ultrasound companies and other stakeholders may submit comments on this document via email by referencing “MDR-Empfehlungen.” Comments should be sent to DGBMT at email@example.com. Comments can be sent in German or English.
Join me in contributing to this important initiative. It will strongly impact the speed for which clinical adoption of focused ultrasound occurs in Europe.
Thomas Andreae, PhD, is the Focused Ultrasound Ambassador, Europe, at the Focused Ultrasound Foundation.