Commissioner Stella Kyriakides proposed an immediate and risk-based extension to the Medical Device Regulation (MDR) transition period today at the E.U. Employment, Social Policy, Health and Consumer Affairs Council. In contrast with their response at the June 2022 meeting, Member State health ministers widely applauded the plan and agreed to support it.
Regulatory background – Notified Body capacity and device and IVD certification
- Implementing the new regulations has been an ongoing challenge since the date of entry into force in May 2017. The regulations weren’t complete as published in 2017; the Commission planned to build out the missing processes via implementing regulations after publication but before the dates of application – May 2021 for the medical device regulations (MDR) and 2022 for the IVD regulations (IVDR). Numerous tools stakeholders needed weren’t in place by the date of entry into force (a big example being the EUDAMED device and sponsor registration database) and the Commission and the Medical Device Coordination Group (MDCG) had to work to put stop-gap processes in place due to the absence of these tools.
- One of the primary issues is that Competent Authorities and the Commission have designated far fewer Notified Bodies than is needed. In the text of both the medical device regulation (MDR) and IVD regulation (IVDR), the Commission recognized in Recital 95 that it is “particularly important that, by the date of application of this Regulation, a sufficient number of notified bodies be designated in accordance with the new requirements so as to avoid any shortages of devices on the market.” The regulations allowed designation of the first Notified Bodies as early as November of 2017, but no Member State Competent Authorities (CAs) did so until May 2019. Between November 2019 and May 2021 (the MDR date of application), CAs designated 20 MDR Notified Bodies, and between May 2021 and today, sixteen more have been designated to that regulation. IVDR designations have gone significantly slower, with just two each year since 2019, and just one so far in 2022 (May 2022 was the IVDR’s date of application).
- Two Notified Body surveys in 2022 confirmed the capacity issues. Team-NB and the Commission carried out two similar surveys of medical device and IVD Notified Bodies, Team-NB publishing results in May 2022 and the Commission building on those results with a second survey in October 2022. While the actual numbers in the two surveys differ slightly, this is largely due to Team-NB surveying its members, not all of whom have received MDR or IVDR designation, and the Commission conducting a wider Notified Body survey that included some non-Team-NB members. The surveys included both MDR- and IVDR-designated Notified Bodies, as well as those not designated and still operating under the directives. The two surveys confirmed that more than 90% of existing certificates hadn’t yet been converted to the new regulations, the rate of certification for all designated Notified Bodies is about 6,000 certificates per year, and the October survey noted that over 17,000 certificates issued under the directives expire in 2024 alone, leaving a deficit of about 11,000 certificates in 2024, the last year of validity for medical device directive certificates.
- At the June 2022 EPSCO meeting, Health Minister Stella Kyriakides outlined MDR implementation progress, but Member State regulators were still concerned. Continued availability of medical devices was on the minds of Member State health ministers at the June E.U. Employment, Social Policy, Health and Consumer Affairs Council (EPSCO). At that time, the Commission was still trying to avoid amending the two regulations (again) – “We are exploring all options within the existing legal framework and have already identified some possible solution-oriented actions,” said Kyriakides. But Member State representatives pushed back, some asking for legal solutions, some suggesting derogation (MDR Article 97) from all MDR requirements for certain critical devices, and others championing a separate process for orphan and pediatric devices. Others suggested extending the transition period; a number felt legal modifications should be on the table. Ministers also questioned the effect of the regulations on fostering innovation and asked the Commission for specific solutions. [Read AgencyIQ’s analysis of the June meeting here.]
- In late August 2022, the European Commission released a 19-point plan to address challenges and concerns with the implementation of the MDR and IVDR. All plan elements were aimed at increasing Notified Body capacity, improving manufacturer access to Notified Bodies and other actions to avoid device shortages – examples include the use of hybrid audits, lengthening the reassessment period for designated Notified Bodies, potential use of derogations for critical devices, and “sustainable solutions” to address orphan devices. [Read AgencyIQ’s analysis of the plan here.] In the last few weeks, the Commission completed, or at least set in motion, two action items from the plan – it released a formal position paper on the use of hybrid audits and adopted two delegated acts to lengthen the redesignation period for Notified Bodies.
- But even as the Commission carries out the plan, doctors, health societies and others are calling for urgent action, and the popular press has taken notice. This Politico Pro article from November 27 outlines the scope of the device availability problem. Just this week, the European Society of Cardiology put out a “ call for urgent action.” A statement put out by the Biomedical Alliance noted that in a survey it conducted, 53% of physician respondents were already experiencing device shortages and called for the Commission to take “a variety of measures” to ensure the device supply, which could include extending the 2024 deadline, supporting orphan devices, a greater role for expert panels and, potentially, conditional approval processes. The European Society of Cardiology echoed what the Biomedical Alliance reported, noting its own members struggling to obtain needed medical devices, especially for children and rare diseases. Other trade organizations have also offered solutions, some of which include shortening the Notified Body designation process timelines, allowing fully remote audits, fast-track pathways for well-established technologies, and abolishing the sell-off provision (the one-year period after legacy device certificates expire in 2024 where if they are already placed on the market, they can continue to be sold). [ Read AgencyIQ’s analysis of what trade organizations have been advocating.]
The Commission sent a report to the Council in preparation for the December 9 meeting
- The report discusses the “state of play” of the MDR in response to concerns raised at the June EPSCO meeting. First, the Commission noted that MDR now has 36 designated Notified Bodies (notably, the report came out before the 36th was announced on December 8) and IVDR eight (the eighth hadn’t yet appeared in the NANDO database as of 3 p.m. ET December 9, 2022). In November, designated Notified Bodies estimated that they could issue “around 7,000” certificates by May 2024, but the number of certificates expiring at that time will be over 17,000.
- The Commission outlined progress made on the 19-point plan. The Medical Device Coordination group released guidance on appropriate surveillance of IVDs covered by certificates issued under the directives as well as a position paper on the use of hybrid audits by Notified Bodies. Stakeholders met with the MDCG taskforce on orphan devices to discuss a formal definition as well as possible regulatory solutions to the market challenges faced by those devices. The Commission also just adopted two delegated acts to lengthen the re-assessment period of Notified Bodies.
- Ongoing work includes revising the guidance on sampling of technical documentation, appropriate surveillance and significant changes under the MDR. New guidance being worked on includes “practical application” of clinical evidence for legacy devices and the use of conditional certificates issued by Notified Bodies. The MDCG is also evaluating how to define what kinds of dialog between Notified Bodies and manufacturers would not be considered consulting, which is forbidden under MDR Annex VII 1.2.3(d). The report also noted that the EU4Health Work Programme built in funding and assistance for Notified Bodies (existing and new), small and medium-sized enterprises, and manufacturers.
- The use of derogations for “other non-compliance” and monitoring of the market: Article 97 allows Member States to permit the use of products that aren’t MDR-compliant but do not “present an unacceptable risk to the health or safety of patients, users or other persons or to other aspects of public health.” This is a temporary measure to allow the manufacturer to bring the product into compliance “within a reasonable period of time clearly defined by the competent authority. MDCG agreed to publish a paper describing that approach after the EPSCO Council meeting on 9 December 2022.” At the same time, using funds from the EU4Health Programme, the Commission will closely monitor the number of devices and certificates and examine “how the MDR supports innovation.”
- The Commission will present “additional [legislative] measures” to the EPSCO Council: Since June, Member States, members of Parliament and other stakeholders repeatedly observed that the 19-point plan is not, in itself, sufficient to guarantee continued availability of medical devices, adding calls for an MDR amendment to extend the transitional provisions outlined in MDR Article 120 and the validity of directive certificates. A rough outline of what that might look like is described in the report. It might include altering Article 120 to introduce staggered deadlines according to the device risk classification – 2027 for risk class III and IIb, and 2028 for class IIa and any class I devices needing Notified Body involvement (measuring function, sterilized, reusable surgical instrument). The sell-off provision would also be removed. Notably, this would only apply for devices for which manufacturers have already started the certification process; the devices can’t undergo significant changes or otherwise “present any unacceptable risk to health and safety.”
- The Commission commits to “tackle more structural issues that have appeared” – i.e., niche (“orphan”) devices.
- Comprehensive evaluation of the MDR – By 2027, the Commission will evaluate whether the new regulations are doing what was intended or are having “a negative impact on patient safety, public health or medical innovation.”
At the December 9, 2022 meeting, the Commission promised a risk-based extension to the MDR transition period
- Czech President Rady summarized the issue: By May 2024, we need to recertify tens of thousands of devices, we need innovative devices, but Notified Body capacity isn’t sufficient and there is a real risk that most may expire and no longer be available on the European market. “That would impact directly the accessibility of healthcare or its continuity. Safety of patients is now directly threatened and we need to take corrective steps as soon as possible,” Rady observed, before introducing Commissioner Stella Kyriakides to speak for the Commission.
- Kyriakides was brief: in response to Rady’s observations on the threats to patient safety, she noted “This is a risk that we cannot take.” While briefly summarizing progress on the 19-point plan introduced in August, she agreed that more needs to be done.
- Kyriakides outlined the specifics of the extended transition. Similar to what was done for the IVDR in January 2022, the proposal is a risk-based transition, with high-risk devices needing to transition by May 2027, a three-year extension, and moderate and lower risk devices transitioning by May 2028 – four additional years. The proposal will also remove the sell-off date for legacy products already placed on the market at the end of the transition period. The only conditions mentioned to take advantage of the extended timeline is that the devices must be safe. Kyriakides promised the proposal at the beginning of 2023.
- Member State responses were more supportive and uniform than at the June meeting. In June, most ministers, led by Germany, France and Ireland, suggested additional measures beyond what the Commission outlined. Today, virtually all agreed that the transition extension is the solution needed and it’s needed as soon as possible. Many also mentioned the need for niche device solutions and a thorough review and root cause analysis of the challenges experienced in implementing the regulations, which the Commission has offered as part of its actions. A number of ministers also reminded the Commission that certificates issued under the directives also need an extension of validity, for those already expired or expiring before the end of the transition period. Italy noted that a mechanism is needed to avoid a shortfall of devices on the market (not just niche devices) and mentioned the derogation process in Article 59 of the MDR. While this was mentioned in the Commission’s report to EPSCO in advance of the meeting, Kyriakides didn’t bring it up in her presentation. Finally, Sweden, as the incoming president, promised its full support in addressing these solutions urgently. Only one Minister, from Malta, took slight issue with the proposal, wanting a single transition date rather than two, to avoid any confusion.
- All stakeholders will undoubtedly welcome the extension. Manufacturers have more time to get files, clinical evidence and any new testing completed and continue to try to engage a designated Notified Body, if they haven’t already done so. The EUDAMED working group has a little bit of pressure lifted but presumably will still try to complete the database by the end of 2023, for an audit in early 2024. And the Commission and the MDCG have more time to figure out how many devices they might lose from the market due to the increased cost and time burden for sponsors trying to comply with the regulations.
- This concession was a long time in the making but at this point it’s absolutely necessary to avoid the 2024 mass certificate expiration. Both the Commission and Team-NB have run the numbers and concluded that it’s just not possible to issue all the certificates needed, especially in 2024. Reuters, reporting on the MDR extension presented at the EPSCO meeting today, spoke with doctors and manufacturers, who noted that “supplies of some products are running low even before the 2024 deadline.”
- Is the issue just with niche products? With news reports of products being unavailable, there may be another problem. While many have been focusing on the continued availability of “niche” products (i.e., orphan and pediatric devices), the MDR effect likely extends to more common but low margin products as well, something the Commission needs to understand quickly – likely (hopefully) high on the agenda of the review of the regulation).
- Does the Commission have a handle on manufacturers’ planned portfolio reductions? This AgencyIQ analyst worked in industry in 2017 when the regulations were released. One of the first actions most firms took upon release of the regulations was to analyze their own product portfolios to remove products with margins too low to justify the expense to bring up to the new standard, as well as those where the documentation and remediation would just be too significant to warrant the time, money and effort. Here is where Europe may be hurt the most and this remains largely unquantified. This will be critical for E.U. regulators to understand, especially since use of the registration database is still voluntary, so it’s difficult to know if the data within it are representative at all. They will need another way to find out, perhaps by engaging Notified Bodies to quiz manufacturers.
- Commissioner Kyriakides didn’t speak any specifics to the IVDR. The IVD regulation has suffered this fate since publication. It came out at the same time as the MDR but had a longer transition built in because the IVDR represented a larger regulatory lift and bigger changes than the MDR did – the IVD risk classification scheme was upended and the number of IVDs requiring Notified Body oversight skyrocketed under the new regime. For the first five years (and continuing), the focus and efforts and guidance mostly targeted the MDR, though of course where the regulations are parallel, the efforts applied to both. This could be the next big challenge, with very few Notified Bodies to oversee at least four times (and likely much higher) the number of IVDs, an entirely new risk classification scheme, and manufacturers who aren’t used to any Notified Body oversight.
- Are derogations still on the table? These were mentioned as part of the solution in the report sent to EPSCO ahead of today’s meeting but were not part of the solutions Kyriakides outlined for the council. Certainly, at least one Member State Commissioner mentioned this as part of the solution to keep devices on the market. This may increase in importance given the questions raised above on low margin devices.
- Expect the eighth IVDR Notified Body to drop any second. Kyriakides mentioned eight IVDR Notified Bodies, but NANDO is still showing seven. This will keep 2022 on par with previous years for two IVDR designations per year. Whether this is sufficient remains to be seen.
- Sweden is taking over as Council president in January 2023 (through June). As the current president from the Czech Republic (Rady) noted, the Swedish president will be the one to see if the immediate actions taken by the Commission look to be effective, at least in the short term.
- The regulation review will be important. While the extension will address the 2024 deadline, it’s not clear that it addresses the problem of manufacturers removing products from the market due to the increased time and expense to get and maintain MDR certification, as noted above. This is something the Commission will need to get a handle on as part of its review of the regulation.
To contact the author of this item, please email Corey Jaseph.
To contact the editor of this item, please email Kari Oakes.
Key Documents and Dates
- EPSCO December 9, 2022 meeting announcement
- EPSCO December 9, 2022 health meeting – provisional agenda
- EPSCO December 9, 2022 health meeting – background brief
- Commission report: Implementation of the Medical Device Regulation – Information from the Commission (123405/EU XXVII.GP), posted December 7, 2022