Regulation (EU) 2023/607 extends the validity of the certificate of medical devices until 2027 or 2028 based on the risk class.
Medical Device Regulation
In May 2017, the Medical Device Regulation (MDR – EU Regulation 2017/745) was published with the aim of redefining the rules on the marketing of medical devices. The MDR repealed Directive 93/42/EEC.
Among the innovations introduced by the Regulation we mention the adoption of the UDI system, the introduction of the declaration of conformity, the optimization of post-marketing surveillance, the recertification of Notified Bodies, the reclassification of some medical devices and the introduction of EUDAMED, the European database for medical devices.
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With the Covid-19 pandemic, the date of applicability had been postponed by one year, to 26 May 2021, but the end date of the transitional period had remained unchanged, 26 May 2024, the day by which medical devices can be placed on the market. market.
MDR extension: the reasons
The times established with the MDR were not sufficient to get stakeholders to make all the required changes. In fact, the designated notified bodies, which are currently 38, are not sufficient to evaluate and certify the more than 21,000 medical devices by 26 May 2024. Furthermore, many manufacturers, especially small and medium-sized enterprises, are unable to demonstrate compliance to the requirements of the MDR. As a result, many devices will not be ready to be legitimately brought to market in time.
To remedy a shortage of medical devices and to ensure the placing on the market of products that have already started the evaluation process by a Notified Body, the European Commission published an amendment proposal to the Regulation on 6 January 2023. This aims to extend the validity period of certificates and the transition period during which devices can be placed on the market.
The proposal was approved by the European Parliament on 16 February 2023 and was consequently adopted by the European Council. On 20 March 2023, Regulation (EU) 2023/607 was therefore published in the Official Gazette, with immediate entry into force, which modifies the transitional period of the MDR (EU Regulation 2017/745) and the IVMDR (EU Regulation 2017/746).
MDR extension: what changes
The extension, sanctioned with Regulation 2023/607, intends to allow more time to fulfill the requests of the MDR for all those devices that require the intervention of a Notified Body. Therefore, the transitional period is extended by amending Article 120, as well as Articles 122 and 123.
Extension of validity of medical devices
According to the MDR, the date by which the recertification of medical devices had to take place was May 26, 2024. With the new Regulation, the certificates of devices that were compliant according to the Directive on May 26, 2021, will continue to be valid and therefore the products will be able to continue to be placed on the market until:
- December 31, 2027 for high-risk devices. That is, all class III devices and class IIb implantable devices (except suture materials, staples, dental filling materials, braces, dental crowns, screws, wedges, plates and prostheses, wires, nails, clips, and connectors) ;
- 31 December 2028 for medium and low risk devices. That is, class IIb devices other than those above, class IIa devices and class I devices sterile or with a measuring function.
These extensions are applicable provided that:
- those devices continue to comply with Directive 90/385/EEC or Directive 93/42/EEC, as applicable;
- there are no significant changes in the design and intended purpose;
- the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health;
- no later than 26 May 2024, the manufacturer has put in place a quality management system in accordance with Article 10(9);
- no later than 26 May 2024, the manufacturer or the authorised representative has lodged a formal application with a notified body with a signed a written agreement.
Furthermore, in the case of a medical device with a certificate compliant with the MDD valid on 26 May 2021, but expired on 20 March 2023, the date of application of Regulation 2023/607, the extension of the transition period is applicable on condition that:
- before the expiry of the certificate, the manufacturer has requested the conformity assessment from a Notified Body and have signed a contract,
- a competent authority has granted a derogation from the conformity assessment procedure or has requested the manufacturer to carry out the conformity assessment.
Extension of validity of customized implantable medical devices
A further extension has been granted for class III implantable custom-made medical devices. These may be placed on the market or put into service without a certificate issued by a notified body in accordance with the conformity assessment procedure, up to:
This extension is applicable if:
• by 26 May 2024 the manufacturer has submitted a formal application to a notified body for conformity assessment with an agreement signed by 26 September 2024.
Extension of validity of in vitro medical devices
As regards in vitro medical devices, an extension had already been introduced with Regulation (EU) 2022/112. Therefore, there is no news. In vitro medical devices for which the conformity assessment procedure pursuant to the Regulation requires the intervention of a notified body, can be placed on the market or put into service until:
- 26 May 2025 for class D devices;
- 26 May 2026 for class C devices;
- 26 May 2027 for class B devices;
- 26 May 2027 for class A devices placed on the market in sterile conditions.
Medical device post-marketing surveillance
The post-market surveillance activity of medical devices remains the responsibility of the notified body that issued the certificate of conformity.
However, the manufacturer may designate a new ON responsible for this activity through an agreement between the two parties and possibly also with the certifying ON. In this case, the new body will not be responsible for the certification issued by the previous one.
Medical device sell-off date
The sell-off date, i.e. the date beyond which legacy devices placed on the market can no longer be marketed, has been removed. Devices, including in vitro devices, placed on the market before or during transition periods and which are still in the supply chain will be able to continue to be made available without time limits.
EUDAMED, the European database for reporting adverse events from medical devices, is not yet active. Therefore, no changes to the regulation were reported.
Medical devices will be able to continue to circulate on the basis of active certificates until a new date. Manufacturers will therefore have more time to have medical devices certified by notified bodies. No changes or extensions for all devices that do not require the intervention of a notified body.