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American medical device manufacturers are amongst the biggest suppliers to Europe’s medical devices market. EUCOPE’s Leander Vranken breaks down the most recent amendments to the EU’s Medical Devices Regulation (MDR) and In-Vitro Diagnostic Devices Regulation (IVDR) and how they will affect medtech and biotech companies.
As of May 2021, the European Union’s Medical Devices Regulation (MDR) came into full effect, followed a year later by the In-Vitro Diagnostic Devices Regulation (IVDR) in May 2022. Any (diagnostic) medical device manufacturer that wants to operate and do business in the European Union (EU) must comply with the MDR and IVDR regulatory structure.
In the EU, the MDR governs the approval processes and distribution of medical devices, while the IVDR regulates the sales and production of in-vitro diagnostic medical devices. Essentially, the idea of both regulations is to harmonize the regulatory review and approval processes of medical and diagnostic devices across all EU member states.
Why the EU MDR/IVDR could lead to medical device shortages
Over the past year, several U.S. and EU stakeholders, including national and EU-level policymakers, have warned that the implementation processes of both the MDR and IVDR could lead to severe shortages of medical devices and medical tests in Europe. These are key to preventing, diagnosing, and treating severe diseases such as cancer.
Combined with the increased demand for conformity assessment, one of the main issues making re-certification a challenge is the limited number of currently designated EU-notified bodies. Notified bodies are organizations designated by EU Member States to assess the conformity of the products with the requirements of the MDR or IVDR.
To add to this, most manufacturers are not yet sufficiently prepared to meet the requirements of both the MDR and IVDR as many have not managed to adapt internal compliance systems/procedures. This signifies the need for further proactivity in the space. Until recently, most stakeholders estimated that the vast majority of medical devices and tests would not get certification on time at all. With the old certificates issued under the previous Medical Devices Directive (MDD) and In-Vitro Diagnostic Directive (IVDD) expiring in May 2024, there was simply no time to get products certified.
The new Regulation (EU) 2023/607
In light of the challenging MDR and IVDR implementation, the Commission proposed to amend the transitional provisions ranging from May 2025 for In-Vitro devices to 2028 for medical devices. The extension of the transition periods and deletion of the sell-off periods come in exchange for manufacturers meeting certain conditions.
EUCOPE’s Senior Legal and Regulatory Affairs Advisor, Dr. Axel Korth, explains that the extension of the transition periods and deletion of the sell-off periods comes in exchange for manufacturers meeting certain conditions. The purpose of this is that only those manufacturers shall benefit from the additional time granted who have taken steps to transition towards compliance with the MDR.
According to Axel Korth, the Commission, as well as the Parliament and the Council, want to see tangible and enforceable steps towards establishing compliance with the MDR and the IVDR but at the same time manage the balancing act as part of their clear mandate and responsibility to prevent a public health crisis and to ensure continued and immediate access to life-saving medical devices.
What it means for medical device manufacturers
For the MDR, the new Regulation gives more time to certify so-called “legacy” medical devices. This means those devices are covered by a certificate or a declaration of conformity issued before 26 May 2021 under the MDD until December 2027 or 2028, depending on which device class.
There are currently only 38 notified bodies for MDR conformity assessment with still over 20,000 certificates that need to be transferred from MDD to MDR. Norgine’s Global Head of Regulatory Affairs, Jörg Plessl, explains the current limited notified body capacity can still cause delays in the conformity assessments and that the MDR could lead to significant delays for these medical devices companies to obtain CE marking under the MDR for their products.
It is of utmost importance that notified bodies avoid duplications and develop a framework for leveraging evidence from previous assessments conducted under the MDD.
‘‘Basically, putting the right focus on new and changed requirements,” states Plessl.
What it means for In-Vitro Diagnostic Device manufacturers
For the IVDR, the extension of its transition period ranges from 26 May 2025 for high-risk in vitro diagnostics to 26 May 2027 for lower-risk in vitro diagnostics, and to 26 May 2028 for certain provisions concerning devices manufactured and used in health institutions.
Megan Doyle, Director of Global Regulatory and R&D Policy at Amgen, points out that the IVDR is leading to delays in clinical trials and European access to clinical trials. The IVDR requires that EU member states approve a study application for the diagnostic, prior to initiating the clinical trial. This is in addition to other requirements, such as authorization of a clinical trial application for the medicinal product study and ethics committee approval. Doyle explains that the critical infrastructure and a coordinated approach to authorizing studies that involve an IVD are not yet available. As a result, sponsors must submit an application to every Member State individually, which is inefficient, time-consuming, and can result in further delay.
The IVDR envisioned a coordinated review of these applications, whereby sponsors can submit a single application and a single Member State coordinates the feedback. However, this process will not be available until 2029. In the meantime, clinical trial sponsors are facing variable expectations and delays in the approval of clinical studies that involve an IVD.
Get ready for the EU MDR/IVDR
The MDR and IVDR are meant to bring EU legislation in line with technical advances, changes in medical science, and progress in lawmaking. The new Regulations intend to create an internationally recognized regulatory framework that improves patient safety and creates fair market access for manufacturers. In contrast to Directives, Regulations do not need to be transformed into national law. Based on that, the MDR and the IVDR should reduce the risks of discrepancies in interpretation across the EU market.
Nevertheless, the limited number of notified bodies, in combination with the increased demand for conformity assessment, could lead to significant delays in obtaining CE marking under the MDR. Delays can also be attributed to the IVDR, as compliance dates have not been extended for new diagnostics under development or used in clinical trials, the IVDR is leading to delays in clinical trials and European access to clinical trials. Typically, non-EU manufacturers suffer the most from these regulatory changes, so communication and research are crucial.
Currently, transitional periods are planned to smooth the application of the new Regulations. If you are a U.S. medical device manufacturer operating in, or planning to do business in the EU, it is paramount to establish compliance with the MDR and the IVDR as soon as possible to avoid delays and be better prepared for the conformity assessment. A proactive approach to comply with the new regulations — including development of plans for transition and proper allocation of resources — should be prioritized as an important organizational milestone.
The discussion on Medical Devices Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) implementation should also be seen in the context of the ongoing discussions and interactions of the Medical Devices Coordination Group (MDCG), dedicated to notified capacity and readiness issues concerning MDR and IVDR implementation.
Should you be interested in learning more about our work within the MDCG working group or wish to join EUCOPE’s MDR/IVDR Focus Group, please contact Leander Vranken (vranken@eucope.org).
Do you like this story? Read Leander Vranken’s piece, How the European Health Data Space (EHDS) will affect companies operating in the EU.
