May 2021 brought with it the adoption of the anticipated Medical Devices Regulation (EU) 2017/745 (‘MDR’). The regulation, which entered into effect after a long awaited four-year transitional period that was extended due to the Covid-19 pandemic, various changes affecting all relevant markets and players which are now being noted in practice by stakeholders and practitioners in the area.
The amendments
The European Commission describes the aim behind the updated MDR and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (‘IVDR’), to be the alignment of “EU legislation […] with technical advances, changes in medical science and progress in law-making”. However, even just a few months after its implementation, questions have already started being raised as to how the MDR corresponds to the needs of the market and the medical devices field, particularly when considering the relations with Switzerland and the role of AI in medical devices.
This modernisation of the regulatory EU medical devices framework brings with it many changes, with the revised definition of the term ‘, some further MDR amendments include:
- A life cycle-approach regarding medical devices;
- A new risk classification system for medical devices;
- Stricter ex-ante control for devices classified as high risk;
- More transparency and better traceability of medical devices following the introduction of the Eudamed database and the Unique Device Identifiers; and
- The obligation on manufacturers and EU representatives to appoint a person responsible for regulatory compliance.
Further guidance
Concepts such as the role of the ‘state of the art’ and that of standards in the sector are noted, and focus is placed on setting out the governance structure for harmonised European standards and the benefits that these can lead to in terms of legislation compliance. Similarly, the European Medicines Agency, having published an update on its “Questions & Answers” for applicants and marketing authorisation holders of medicinal products, provides a directly practical guide to companies as to the implementation of the MDR and IVDR and other practical considerations for issues that may arise in this implementation.
In spite of the novel introductions and steps taken towards a harmonization of European standards and holistic digital approach, examples of the practical effects of the MDR have already started to show.
Practical effects on the horizon
In spite of the novel introductions and steps taken towards a harmonization of European standards and holistic digital approach, examples of the practical effects of the MDR have already started to show.
The Commission’s to stakeholders on the Recognition Agreement (MRA) between the EU and Switzerland has been characterised as a shrinking of the internal market for the trade of medical devices that comes with devastating consequences when taking into account the new MDR. Given the lack in updating the relevant parts of the MRA to match the amendments, the of the Agreement no longer apply. This is due to the fact that parts of the MRA, such as the mutual recognition of conformity assessment results, the absence of the need for an authorised representative and the alignment of technical regulations, are no longer in accordance with the MDR. This does not only come with practical implications in the import and conformity of medical devices but it also is bound to have financial repercussions given the amount of exports of Swiss medical devices to the EU. This further tightens the rope in this field between the two parties, for which the regulatory adjustments history dates back to 2014. This in return creates a sense of urgency in updating the MRA in order to reflect the amendments brought in by the Regulation or further guidance from the Commission on this issue.
Applicants and relevant authorities will have to tackle unique challenges when AI and healthcare are connected.
Another important practical takeaway that has been noted to arise from these amendments relates the unique challenges that applicants and relevant authorities will have to tackle when AI and healthcare are connected. Firstly, regulators now have to be able to have thorough knowledge and provide answers to how medical device software is to be regulated when AI algorithms form a part of the device’s programming. The MDR requires software devices to be designed in a manner that ensures repeatability, reliability and performance in line with their intended use. However, these requirements are typically easier to satisfy when developing and programming conventional software algorithms. In the event where AI is involved in the process or forms an integral part of the software, this is much harder as AI and machine learning application are more often tested and trialed using big data sets and, as the name would suggest, “learn” from errors. This in return makes the validation and verification using the existing standards more difficult.
MDR and IVDR: looking into the future
Interestingly, the IVDR has not received the same characterisations as the MDR. The IVDR brings with it changes affecting the labels of In Vitro Devices (‘IVDs’), the new classification system for IVDs and the requirement for certificates issued under the IVDR and by notified bodies to name a few. However, associations have stated that these changes should have “no particular impact on registrations” given that all jurisdictions allow additional information to be provided with an IVD. While the IVDR applies as of May 2022, the full effect that the MDR has started to show and is very likely to become more evident in the months to follow, given the emerging and ever-developing field it regulates as well as the policy climate at present and inter connection between the field of AI and healthcare.
Author: Maria Christofidou, PhD Student at the Department of Public Health & Primary Care (Ghent University) and member of the Metamedica-platform.
References
- Medical Devices Regulation (EU) 2017/745
- In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746
- European Commission, ‘Getting ready for the new regulations’. Accessible at: https://ec.europa.eu/health/md_newregulations/getting_ready_en
- European Medicines Agency, ‘Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746)’, updated on 29 June 2021. Accessible at https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices#medical-devices-legislation-section
- European Commission, Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices, 26 May 2021. Accessible at: https://mcusercontent.com/80a2795e9aa8aacac0c148b3b/files/305992b6-5b13-4847-8d52-6f238e889a09/Medical_Devices_Switzerland_Notice_to_Stakeholders_26052021.01.pdf
- European Commission, Statement on the decision by the Swiss Federal Council to terminate the negotiations of the EU-Swiss Institutional Framework Agreement, 26 May 2021. Available at: https://ec.europa.eu/commission/presscorner/detail/en/statement_21_2683
- European External Action Service, Basic Facts on the Framework of EU-Switzerland Relations, 25 May 2021. Accessible at: https://eeas.europa.eu/headquarters/headquarters-homepage/85745/basic-facts-framework-eu-switzerland-relations_en
- Van Bael and Bellis, Life Sciences Newsletter, ‘Medical Devices – Free Market Access between European Union and Switzerland Given Blow’, 31 May 2021. Accessible at: https://mailchi.mp/vbb/medical-devices-free-market-access-between-european-union-and-switzerland-given-blow?e=b2763e8e1b
- MedTech Europe, ‘Impact of changes under the new EU IVD Regulation (EU) 2017/746 to international registrations’, 26 May 2020. Accessible at: https://www.medtecheurope.org/wp-content/uploads/2020/05/20200526_Impact_Changes_Int_Reg_invitrodiagnostics_IVDR.pdf
- Hamza Zourakhti, Loyens & Loeff, ‘Medical Devices Regulation (MDR) entered into effect’, 27 May 2021. Accessible at: https://www.loyensloeff.com/nl/en/news/news-articles/medical-devices-regulation-mdr-entered-into-effect-n22603/
- Charleen O’Keeffe, Laura Scott and Darragh Larkin, William Fry, ‘MDR Countdown – 1 Month. European Commission Updates its Rolling Plan’, 23 April 2021. Accessible at: https://www.williamfry.com/newsandinsights/publications-article/2021/04/23/mdr-countdown-1-month.-european-commission-updates-its-rolling-plan
- Martin Kelleher and Niall Collins, Mason, Hayes & Curran, ‘New EU Guidance on Standardisation for Medical Device’, 21 July 2021. Accessible at: https://www.mhc.ie/latest/insights/new-eu-guidance-on-standardisation-for-medical-device
- Michaela Herron, Martin Kelleher and Niall Collins, Mason, Hayes & Curran, ‘AI in Medical Devices: Key Challenges and Global Responses’, 22 July 2021. Accessible at: https://www.mhc.ie/latest/insights/ai-in-medical-devices-key-challenges-and-global-responses