Clinical Researcher—April 2023 (Volume 37, Issue 2)
Clare Huntington, MSc
With thousands of outstanding conformity assessments for medical device certification under the Medical Device Regulation (MDR) and limited capacity to manage these within the transition period, concerns over widespread product shortages in the European Union (EU) market have been growing.
To mitigate this risk, the European Commission (EC) proposed an extension of the transition period.
European Health Commissioner Stella Kyriakides noted that “the transition to the new rules has been slower than we anticipated,” and pointed to several contributing factors:
- The COVID-19 pandemic
- Shortages of raw materials caused by the Russian invasion of Ukraine
- Low notified body capacity
It has been estimated that 23,000 devices and 1,500 in vitro diagnostics (IVDs) certified under the previous directives had not yet transitioned to the new regulation, and these certifications were likely to expire in May 2024 and May 2025, respectively.
As the end of 2022 approached, it became clear that, with just 36 Notified Bodies designated for medical devices and only eight for IVDs, there would not be sufficient capacity to maintain existing products on the market and bring new products and innovations to EU markets.
This created the potential for shortages of life-saving medical devices for patients, which Kyriakides noted was “a risk that we cannot take.”
Rethinking the Deadlines
With these concerns in mind, Kyriakides proposed at a meeting of the Employment, Social Policy, Health, and Consumer Affairs Council in Brussels that an amendment be introduced to the MDR to postpone the transitional deadlines.
This targeted amendment was proposed to include staggered deadlines, depending on the risk of each device, and would be subject to certain conditions to ensure they apply only to devices that do not present any unacceptable risk to health and safety. These devices should also not have undergone significant changes in design or intended purpose. Furthermore, manufacturers are expected to have undertaken the necessary steps to launch the certification process under the MDR.
On 16 February 2023, the EU Parliament adopted the proposal, which the Council adopted on 7 March. The final step before full acceptance was publication in the Official Journal of the EU (OJEU), which was actioned on 20 March 2023.
Under this new Regulation, (EU) 2023/607, most devices certified under the previous Medical Devices Directive (MDD) or Active Implantable Medical Devices Directive (AIMDD) may be placed on the market until:
- 31 December 2027 for Class III and IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors; or
- 31 December 2028 for lower risk devices (Is, Im, IIa, remaining IIb devices not covered by the point above), as well as devices that were Class I under MDD and require an assessment by a notified body for the first time under MDR.
The extension also applies to devices with certificates that expired between 26 May 2021 and the date of publication, on certain conditions.
First, the manufacturer and the notified body must have signed an agreement for the conformity assessment of the device covered by the expired certificate, or a device intended to substitute that device before the expiry of the certificate. Second, a national competent authority has granted a derogation.
Conditions to be met to qualify for the extension
There are a few conditions the devices and manufacturers must meet to be granted an extension. These include that the devices must continue to comply with MDD/AIMDD; that there are no significant changes in the design and intended purpose; and that the devices do not present an unacceptable risk to patients, users, third parties, or public health.
There are also requirements that manufacturers implement a quality management system as described in MDR article 10(9) before 26 May 2024. In addition, the manufacturer (or authorized representative) must have applied to a notified body for the conformity assessment of these devices, or the devices intended to replace them before 26 May 2024, with the agreement signed no later than 26 September 2024.
Specific arrangements for post-market surveillance
Despite the extension, the requirements for post-market surveillance, market surveillance, vigilance, registration of economic operators, and devices described in the MDR apply, replacing the corresponding requirements of MDD/AIMDD.
The notified body that issued the certificate under MDD/AIMDD continues to be responsible for the surveillance of these devices, unless the manufacturer has a written agreement that the notified body responsible going forward, if different, will continue such surveillance.
The transfer of responsibility between the two notified bodies must occur before 26 September 2024 and should be clearly defined in an agreement between the manufacturer and the two notified bodies.
Specific arrangement for Class III custom-made implantable devices
The requirement for Class III custom-made implantable devices to obtain a certificate from a notified body has been postponed until 26 May 2026, as long as the manufacturer has submitted an application to a notified body before 26 May 2024 and has signed an agreement no later than 26 September 2024.
Removal of the time limit for placing medical devices and IVDs into service
In addition to the latest date for placing devices on the market, the MDR and In Vitro Diagnostic Regulation (IVDR) both introduced a date until which devices could legally be made available or put into service (26 May 2025 for medical devices, between 26 May 2025 and 26 May 2028 for IVDs). All of these deadlines have been removed by the new regulation, meaning that the devices that have been legally placed on the market can continue to be made available.
The EC believes that this decision will help with the continued supply of medical devices, giving manufacturers and notified bodies more time to work on the MDR implementation. Most importantly, it assures the safety of patients via the post-market surveillance and market surveillance obligations.
Even after publication of the delay, a number of questions remain. Furthermore, some challenges experienced as a result of the implementation of the MDR have not been addressed, such as challenges facing innovative products, including devices with a significant change or that are new to the market.
The EC has prepared a Q&A document that seeks to provide guidance on practical aspects relating to the implementation of Regulation (EU) 2023/607. It is expected that this will be updated regularly in the coming months. It provides feedback on the following subjects:
- Scope of the extension of the MDR transitional period
- Evidence of extended transitional period
- Conditions to be fulfilled to benefit from the extended MDR transition period
- Appropriate surveillance to be performed by Notified Bodies
- Deletion of the “sell-off” date
Even with the delay now in force, the advice remains the same: companies should continue to transition to the MDR and IVDR as soon as they can. This will allow them to focus on marketing and improving their products. Moreover, there may be future bottlenecks with Notified Bodies as the new deadlines approach, and companies that are ready to transition will be in a better position to market MDR/IVDR-approved products globally.
Press release from 6 January 2023—Public health: more time to certify medical devices to mitigate risk of shortages Public Health: medical devices (europa.eu)
Regulation (EU) 2023/607 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 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2023.080.01.0024.01.ENG
Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices https://health.ec.europa.eu/system/files/2023-03/mdr_proposal_extension-q-n-a.pdf
Clare Huntington, MSc, is Director, Head of Medical Devices/IVD UK for PharmaLex.