On 9 December 2022, a proposal to extend the transition periods in Regulation (EU) 2017/745, the Medical Device Regulation (shortcut: MDR), was submitted to the EU Commission. On 6 January 2023, the EU Commission published a draft of the new regulations regarding the transition periods, first and foremost Article 120 MDR. The Presidents of the European Parliament and the Council signed the legislative proposal on 15 March 2023. The Regulation (EU) 2023/607 has not yet entered into force, pending publication in the Official Journal. The transition period of the previous regulation in Article 120 (3) MDR expires on 26 May 2024. The reason for the need to extend the periods is that due to the lack of notified bodies, (rapid) certification cannot be carried out for all medical devices until the MDR deadline expires. Currently, there are still 21,376 valid MDD certificates, of which 4,311 certificates will expire in 2023 and 17,095 certificates in 2024. If the deadlines pass and medical device manufacturers do not manage to get their products certified in time, the availability of medical devices on the EU market will be limited.
The essential innovations at a glance
The Regulation (EU) 2023/607 includes an extension of the time periods in Article 120(2), (3) and (4) MDR:
- Class III and IIb implants: new transition period until 31 December 2027
- Class IIb and lower: new transition period until 31 December 2028
- Class III custom-made products: new transition period until 31 December 2026
- No 'sell-off' deadline
For part of the Class I products, the (old) transitional period until 26 May 2021, which is regulated in Article 120(1) MDR, remains in place.
Article 120(2) MDR
Article 120(2) MDR, in the new version, provides that a transition period until 31 December 2027 or 2028 applies if the following conditions are met:
- Certificates under the (no longer valid) MDD that were still valid on 26 May 2021 and have not been withdrawn or
- Certificates that expire before the new regulations come into force are still valid if,
- before the date of expiry of the certificate, the manufacturer and the notified body have signed a written agreement for the conformity assessment in respect of the device covered by the expired certificate or in respect of a device intended to substitute that device or
- a competent authority of a Member State has granted a derogation from the applicable conformity assessment procedure in accordance with Article 59(1) MDR or has required the manufacturer, in accordance with Article 97(1) MDR, to carry out the applicable conformity assessment procedure’.
Article 120(3) MDR
According to the new Article 120(3) MDR, there is the following gradation for the transition periods:
The transitional period until 31 December 2027 applies to class III devices and for class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors. The transition period until 31 December 2028 is foreseen for the remaining class IIb devices, for class IIa devices and for class I devices placed on the market in sterile condition or having a measuring function.
Furthermore, Article 120(3) MDR is amended to the effect that devices which did not need the involvement of the Notified Body for certification according to the MDD, for which the Declaration of Conformity was issued before 26 May 2021 and which now require the involvement of a Notified Body according to the regulations of the MDR, may be placed on the market or put into service until 31 December 2028.
However, these extensions of time limits only apply under the following conditions:
- The units still comply with the MDD (which is actually no longer valid);
- there are no significant changes to the design and intended use;
- the devices do not pose an unacceptable risk to the health or safety of patients, users or other persons or to other aspects of public health protection;
- the manufacturer has established a quality management system in accordance with Article 10(9) MDR by 26 May 2024 at the latest;
- the manufacturer or an authorised representative has submitted a formal application in accordance with Annex VII to the MDR for conformity assessment for a device referred to in this paragraph 3 or for a device intended to replace that device by 26 May 2024 and the notified body and the manufacturer have signed a written agreement by 26 September 2024.
Finally, a transitional period until 26 May 2026 was decided for Class III implantable custom-made devices.
Article 120(4) MDR
The withdrawal periods in Article 120(4) MDR were deleted without replacement. According to the original regulation, products should be withdrawn from the market that were placed on the market before or during the transitional period and are still in the supply chain.
The deletion of the ‘sell-off’ deadline is intended to ensure that the medical devices continue to be available beyond the end date of 26 May 2025.
Procedure for certificates that have already expired
If the certificates expire in the near future, the manufacturer has the option of concluding a written agreement with the notified body. The other option – especially if the certificate has already expired – is to apply to the notified body for an exemption under Article 59(1) MDR or Article 97(1) MDR. Article 59(1) MDR is the regular exemption provision if a manufacturer cannot comply with the regulations on the conformity assessment procedure. Article 97(1) MDR, on the other hand, is actually a regulation on market surveillance. It is used here to allow further exemptions from the conformity assessment procedure, so that as few certificates as possible lose their validity in the end. For the application of Article 97(1) MDR in such cases, the Medical Device Coordination Group published a guidance document in December 2022 (MDCG 2022-18).
Future outlook
On 15 March the Presidents of the European Parliament and the Council signed the Regulation (EU) 2023/607. The entry into force of the new regulations still requires the publication in the Official Journal. It now remains to be seen when the regulations will come into force and thus be applied.
The proposed changes are useful and can avoid bottlenecks in the supply of medical devices for a time. Nevertheless, manufacturers must carefully examine in each individual case whether the longer transition periods may actually be applied to the respective product. In the long term, manufacturers should aim to achieve conformity with the MDR regulations.
