MDR transition period and certification bottleneck
Early action required to ensure compliance under the new regulations
The rapidly approaching deadline to transition legacy devices from the Medical Device Directive (MDD/AIMDD) to the Medical Device Regulation (MDR) has placed extraordinary pressure on the medical device industry, Notified Bodies (NB), and regulatory authorities. As things stand now, medical device manufacturers must comply with EU Regulation (2017/745) on medical devices by 26 May 2024. While the European Commission’s Medical Device Coordination Group (MDCG) originally indicated there would be no extension to the MDR timeline or transition period, circumstances have required that this decision be re-visited. At the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) meeting held on December 9th, the European Commission decided to progress a proposal for legacy devices to extend the transition period in accordance with MDR Article 120. The informal proposal is outlined in the December 6th EU Commission Information Note.1
Subsequently, on January 6th, the EU Commission issued a proposal to extend the MDR transition period for legacy devices covered by a valid MDD/AIMDD certificate issued before 26 May 20212. The new proposed transition periods are to 31 December 2027 for Class III and IIb implantable devices (with some exceptions), 31 December 2028 for all other Class IIb devices, and 31 December 2028 for ‘upclassified’ devices, e.g. Class Ir, software. The proposal also introduces a transition period to 26 May 2026 for Class III implantable custom-made devices as well as removes the ‘sell-off date’ from the MDR.
Should the proposal be adopted, an extension to the MDR transition period will be granted for legacy medical devices that fulfill certain conditions, including: (1) continued compliance with MDD/AIMDD; (2) no significant changes in design and intended purpose; (3) no unacceptable risk to health or safety; (4) establishment of a quality management system by 26 May 2024; and (5) a formal application for conformity assessment is submitted by 26 May 2024 with a written agreement by 26 September 2024.
The MDCG has also issued a position paper (MDCG 2022-18) with details regarding their approach to MDR Article 97 in situations where a legacy device that is not in conformity due to an expired certificate can remain on the market as the manufacturer works to come into compliance with MDR. Article 97 is meant to be a temporary solution in justified cases. The recommendations outlined in this position paper do not require any legislative changes to be adopted.3
If your legacy devices have current certificates, and you are in the process of transitioning to MDR but have not yet received the proper certifications from your NB, this extension, if legislated, may buy you some much needed time. However, even if the transition period is extended, there will still be challenges moving forward due to the problems that caused the EC to consider the extension in the first place.
What is a “legacy device”?
A “legacy device” is a medical device that meets the following criteria:
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Conformity assessment for the device required the involvement of a Notified Body (NB)
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The device(s) were placed on the market prior to 26th of May 2021
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The device(s) have a currently valid MDD (Directive 93/42/CEE on medical devices) or AIMDD (Directive 90/385/CEE on active implantable medical devices) certificate(s) issued prior to 26th of May 2021
These MDD and AIMDD EC Certificates will remain valid until their expiration date or the end of the transition period.
Expiration of current MDD/AIMDD certificates for legacy devices
MedTech Europe reports that, as of April 2022, 85% of currently valid AIMDD/MDD certificates will expire in 2023-20244.
A survey was issued to all medical device manufacturer members of MedTech Europe, receiving 475 responses (60%-70% market coverage), to analyze capacity and found that urgent solutions are needed in order to ensure that patient access and care are not threatened moving forward. Key findings are summarised below:
1. More than 85% of the > 500,000 devices on the market have not yet transitioned to the MDR
a. It takes 13-18 months on average for per device for a successful transition to an MDR certificate (see figure below)
b. a.Progress to certification is slow - around 14% of all certificates (Quality Management System and Technical File) have been issued so far
2. Over half of all survey respondents plan portfolio reductions
a. Companies have decided to pull products from the market due to challenges faced in MDR certification
b. This will have a yet-unknown impact on healthcare systems as it is difficult to predict which medical device categories will be affected
3. Small and medium size companies are more impacted by the transition to MDR than larger companies
a. Small and medium sized companies account for 26% of the total number of devices expected on the market by 26 May 2024, and will require 40% of the total certificates needed
b. Up to 30% of SMEs have either no Notified Body and/or have a Notified Body that is not yet designated to MDR
4. MDCG guidance documents and delays in certification
a. More than 1 in 5 companies have reported delayed in certification due to new or revised MDCG guidance (for example, revisions to MDCG 2021-24 Guidance on classification of medical devices5) or the delay or absence of guidance documents (such as PSUR (Periodic Safety Update Report)). This leads to companies needing to rework submitted applications).
b. Large companies appear to be more impacted by this as they have a larger portfolio and fall into scope of a wider range of guidance documents
The European Commission conducted a similar survey in October 20226. Based on the feedback received from notified bodies, notified bodies have received 8,120 applications and issued 1,990 certificates under the MDR. According to information provided to the MDCG by NBs, the number of MDR certificates issued by May 2024 could reach 7,000 assuming no change to the current rate of certificate issuance. This is a fraction of the 22,793 valid certificates issued under MDD/AIMDD that will expire by 26 May 2024.
To date, there are 36 Notified Bodies designated under the MDR. As it stands, there is not enough capacity to renew all MDR required certificates before the deadline in 2024.
Notified Bodies
As you can see, time is of utmost importance as companies race to receive the proper certifications prior to the MDR deadline.
Source: MedTech Europe Survey Report
The timescale above illustrates that most Notified Bodies are reporting a range of 13-18 months for certification - double the time historically needed. New devices and Class III devices are also more likely to lead to increased timescales. In line with this, the MDCG has issued the following guidance (emphasis added):
"In this context, it is expected that the manufacturer has submitted an application to a notified body for certification in compliance with the MDR at least one year before the expiry date of the MDD/AIMDD certificate"
Due to the MDR certification bottleneck, the European Coordination Committee of the Radiological Electromedical and Healthcare IT Industry (COCIR) has proposed measures to enhance the capacity and preparedness of Notified Bodies7:
- Expand the use of remote audits to all products generally (without need for specific justification)
- Use Medical Device Single Audit Program (MDSAP) reports to introduce efficiencies
- Allow Notified Bodies more flexibility in defining the appropriate technical documentation sampling (e.g. lower number of technical files based on risk class and not on groups)
- Provide guidance on use of performance data and interpret equivalence provisions as pragmatically and flexibly as possible (within legal framework).
Suggested courses of action
MDCG recognised that significant and urgent challenges remain in ensuring that Notified Bodies have the capacity to issue the necessary MDR/IVDR compliant certificates before expiration. As a result, MDCG released a position paper2 summarising their position and views on Notified Bodies and their role in assisting in the 14,000 certificate renewals expiring in 2024, proposing 19 measures that Notified Bodies could take, the first 11 of which are ‘smaller solutions’.
The proposed solutions not falling under the ‘smaller solutions’ label include:
- Making standard fees publicly available and easy to compare
- Develop schemes to allocate capacity for SME manufacturers and first-time applicants
- Timely compliance with MDR requirements
- Organise structured dialogues before and during the conformity assessment process
- Step up communications with manufacturers through webinars, workshops, informative sessions
- Additional guidance to assist with practical application of Article 61 MDR (clinical evaluation)
- Provide additional guidance with regard to orphan devices
- Medicine authorities should accept and efficiently process consultations by notified bodies regarding medical device incorporating an ancillary medicinal substance and regarding companion diagnostics
The MDCG has issued a position paper (MDCG 2022-14) with recommendations on increasing the capacity of NBs as well as other actions to facilitate transition to MDR and avoid device shortages8.
Summary
In summary, companies with expiring certificates must continue to press forward in transitioning their legacy devices to the MDR. As a majority of devices have yet to receive MDR certifications, the strain on resources will continue as Notified Bodies struggle to process the vast number of applications. This bottleneck is leading to innovation leaving Europe as the region becomes deprioritised for first regulatory approval of new devices. Clinical benefits derived from new and improved devices will become available to patients in other countries first, and lack of access to current devices on the EU market will threaten healthcare systems and patient care and may trickle down to countries historically relying on CE marked devices.
ICON’s Medical Device and Diagnostics Research team has over 30 years of clinical development & commercialisation service experience with medical device and IVD companies. Contact us to learn how we can help you navigate the challenges of the new regulations and prepare your business for success.
Sources:
- European Commission Note - Implementation of the Medical Device Regulation (6 December 2022)
- European Commission Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices (6 January 2023)
- MDCG 2022-18 – MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate (December 2022)
- MedTech Europe Survey Report analysing the availability of Medical Devices in 2022 in connection to the Medical Device Regulation (MDR) implementation (14 July 2022)
- MDCG 2021-24 - Guidance on classification of medical devices (October 2021)
- European Commission – Notified Bodies Survey on certifications and applications (MDR/IVDR) (24 October 2022)
- COCIR Position – Proposed actions to enhance Notified Bodies capacity and preparedness (25 July 2022
- MDCG 2022-14 - Transition to the MDR and IVDR. Notified body capacity and availability of medical devices and IVDs (August 2022)