Europe – Aspiring to Safer Devices

In its 2012 explanatory memorandum1, the European Commission outlined its aim to not only improve patient safety but also to support scientific and technological advancement by replacing the previous medical device directives—the “new approach” (93/42/EEC Medical Device Directive, 90/385/EEC Active Implantable Medical Device Directive, and the In Vitro Diagnostic Device Directive). This revision followed intense public scrutiny after the Poly Implant Prothèse breast implant scandal and the metal-on-metal hip recalls.  The Commission emphasized that while the new regulations would close critical gaps to enhance patient safety, they must also foster innovation and maintain the competitiveness of the medical device industry. Rapid, cost-effective market access for innovative devices would benefit both patients and healthcare professionals.

The Medical Device Regulation (EU) 2017/745 (MDR) came into force in May 2017, with full application initially scheduled for 26 May 2021—later extended by one year due to the COVID-19 pandemic2. However, adoption was slow. Contributing factors include a reduction in notified bodies designated under MDR, manufacturers’ hesitancy to invest in clinical data for reclassified existing devices, and delays in establishing practical MDR infrastructure (such as EUDAMED modules and expert panel availability).  Several manufacturers3, despite having proven products, exited the EU market due to a tenfold increase in compliance costs and extended certification timelines—up to 2.5 years under MDR, compared to a few months under the old system. Some allowed certifications to lapse, rendering their devices unavailable to the EU market. In response to these supply chain concerns, the European Commission extended the transitional period for legacy devices to 2027–20284, based on their risk classification.  While this extension helps sustain the current device supply, it does not resolve the broader challenge of meeting regulatory requirements for new, often innovative, devices—especially those targeting unmet clinical needs.

Europe – Expert Panels

Though the MDR is relatively clear in structure and supported by classification guidelines, its full implementation remains incomplete. High-risk, novel devices—typically falling under Class IIb or Class III—frequently involve new biomaterials, unproven technologies (e.g., cell-based or AI-powered), or address conditions with few existing treatments. These characteristics warrant clinical investigations as part of the CE marking process.

Under MDR, notified bodies review a device’s safety and effectiveness evidence before CE marking. For high-risk, novel devices, this is followed by an additional layer of scrutiny from relevant expert panels. Notified bodies, as independent entities,  cannot advise manufacturers on clinical strategies prior to submission, which can be problematic. If an expert panel finds a clinical strategy inadequate after the fact, manufacturers (particularly start-ups) may lack the resources to modify or repeat the study.  Article 61(2) however allows manufacturers to consult expert panels before beginning clinical evaluations or investigations. The panel can review proposed strategies and offer feedback;  manufacturers are required to “give due consideration to the views expressed by the expert panel”. 

The first expert panels were formed following a 2019 call5, and a pilot program for pre-submission clinical advice launched in February 20236. In the first intake to the pilot (41 applicants), 65% were small to medium enterprises.  As of January 2025, EU-based manufacturers (or their authorized representatives) can formally request expert panel consultations—provided they meet all of the following:

• The device is Class III, or a Class IIb active device that administers or removes medicinal products

• Questions asked by the manufacturer pertain to clinical aspects only.

• Questions related to clinical investigations pertain solely to clinical investigations not yet started (pre-market or post-market). 

Consultations are restricted to prospective clinical investigations and there still appears to be no process for Expert Panel access for non-active Class IIb devices.  Details on the regular procedure are outlined in the new guidance document: Guide to manufacturers on the procedure for requesting advice from Expert Panels on clinical investigations and/or clinical development strategies for high-risk medical devices7.  While the full operational launch of expert panels is a welcome development, the scope of discussions remains too narrow. 

During the pilot, Triskele Consulting submitted two successful applications, including one for an orphan device. However, both were eventually withdrawn due to limitations in application scope and uncertainty regarding future orphan device designation.  We agree that while the need to demonstrate safety and effectiveness before market approval is essential to protect patients and uphold public trust, the regulatory framework must also enable timely access to reliable, cutting-edge technologies. The unfortunate reality is that for many homegrown startup companies, it remains difficult to see a realistic pathway to market access to benefit Irish, and other European, patients.

References

1. European Commission, (2012), Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/ED, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009, Brussels: European Commission.

2. European Commission, (2020), Regulation of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions.

3. M. Fick, (2022), “Insight: Medical device makers drop products as EU law sows chaos”, Reuters Press, December, online article available at: https://www.reuters.com/business/healthcare-pharmaceuticals/medical-device-makers-drop-products-eu-law-sows-chaos-2022-12-19/ .  

4. European Commission, (2023), Regulation of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.

5. European Commission, (2019), Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices, September, available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3AC2019%2F323%2F05 . 

6. European Commission (2024), Medical Devices Expert Panels,  https://health.ec.europa.eu/medical-devices-expert-panels/experts/expert-panels_en .

7. European Medicine Agency (2025), Guide to manufacturers on the procedure for requesting advice from Expert Panels on clinical investigations and/or clinical development strategies for high-risk medical devices. Advice to manufacturers for high-risk medical devices. EMA/23357/2025 available at: https://www.ema.europa.eu/en/documents/other/guide-manufacturers-procedure-requesting-advice-expert-panels-clinical-investigations-or-clinical-development-strategies-high-risk-medical-devices_en.pdf