The European Parliament has approved the proposal to delay the Medical Device Regulation (MDR) transition period for some products. The decision means medical devices with a valid EC certificate under an EU Directive (MDD, 93/42/EEC or AIMDD, 90/385/EEC) can continue to be placed on the market under certain circumstances until their certificate expires, or 26 May 2024 at the latest.
European industry associations and Health Ministers had expressed their concerns regarding the upcoming deadline, as a lack of notified body availability and longer assessment periods due to stricter requirements posed a risk of medical device shortages.
The European Parliament decision follows a proposal submitted by the European Commission in December 2022 to introduce a staggered extension of the transition period provided in the MDR (EU 2017/745). This decision is expected to be approved by the Council and published in the Official Journal in the next few weeks.
Under this new regulation, most devices certified under MDD or 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 NB 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, as long as one of the following conditions applies:
- The manufacturer and the notified body 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.
- 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:
- The devices must continue to comply with MDD / AIMDD
- There are no significant changes in the design and intended purpose.
- The devices do not present an unacceptable risk for patients, users, third parties or public health.
- The manufacturers must implement a quality management system as described in MDR article 10(9) before 26 May 2024
- 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
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 2 notified bodies must happen 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 is 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 MDs 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 European Commission estimates 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 still guarantees the safety of patients via the PMS and market surveillance obligations.
What manufacturers should do
Device manufacturers must continue to work on the MDR implementation as planned, particularly to obtain missing data and have technical documentation ready for assessment.
They should contact their current notified body to understand if they expect to become designated under MDR by May 2024 or if they need to find an alternative notified body.
Manufacturers without MDR designated notified bodies should continue their search for one and consider re-contacting any notified body that previously turned them down. Given the new requirements and timelines, we would expect that notified bodies may change their approach toward new customers.
This is good news for device manufacturers and notified bodies that have worked hard since 2017 on the MDR implementation. It is likely the additional time will also allow further guidance or common specifications to be published on topics that are still less well supported to clarify what is expected by notified bodies when reviewing technical documentation.
The PharmaLex medical devices team can support manufacturers in their transition to the MDR with gap assessments, advising on requirements, technical and medical writing or quality management system updates and implementation.
Find out more and contact us at contact@pharmalex.com to discuss.
About the author:
Audrey Toulemonde, Senior Manager, Medical Devices / IVD, UK
Reference:
https://www.europarl.europa.eu/plenary/en/infos-details.html?id=922&type=priorityInfo
https://health.ec.europa.eu/system/files/2023-01/mdr_proposal_factsheet_0.pdf
