Regulation (EU) 2023/607 extending CE certificates for medical devices and in vitro devices came into force

On March 20, 2023, Regulation (EU) 2023/607 (“Regulation”) entered into force, extending the duration of CE certificates for legacy devices under Regulation 2017/745 and the relevant period during which such devices can be placed on the market or put into service, previously scheduled to expire on May 26, 2024. The Regulation also eliminated the “sell-off” period provided for both medical devices and in vitro diagnostic medical devices in Regulation 2017/745 (“MDR”) and Regulation 2017/746 (“IVDR”), respectively.

Please note that only legacy devices can benefit from the extended transitional period. These are devices that, in accordance with the MDR’s transitional provisions, are placed on the market after the MDR date of application (May 26, 2021) if certain conditions are fulfilled. This is also clarified by point no. 1 of the Q&A on the Regulation published on the European Commission’s website on March 27, 2023.

Background

The Regulation originates from the proposed amendment to the MDR and the IVDR adopted by the European Commission on January 6 of this year with the goal of maintaining patient access to a wide range of medical devices during the transition to the new regulatory framework, while also ensuring that these devices are safe.

Under the MDR,^[1] the transitional period when devices certified under Directive 90/385/EEC (active implantable medical devices) and Directive 93/42/EEC (medical devices) may continue to be placed on the market under certain conditions was set to expire on May 26, 2024. However, due to the lack of a sufficient number of notified bodies operating under the MDR and the difficulties encountered by manufacturers in complying with the new MDR requirements, it has been estimated that transitioning all certificates issued under the directives to the MDR will take until December 2027 at the current rate of certificate issuance.^[2]

Consequently, even with an increase in the number of notified bodies, it is very likely that many devices won’t be certified in accordance with the MDR prior to the end of the transitional period, which could lead to a medical device shortage in the European Union.

Accordingly, Regulation (EU) 2023/607 addresses the urgent need to extend the validity of certificates issued in accordance with Directives 90/385/EEC and 93/42/EEC, as well as the transitional period during which devices compliant with these directives lawfully may be placed on the market or put into service.

The Regulation also eliminates the “sell-off” deadline in the relevant MDR and IVDR provisions.^[3] This was the end date for making available devices placed on the market before or during the transitional period.

Extension of certificates and the MDR transitional period

Article 1, par. 1 of the Regulation extends the validity of CE marking certificates issued under previous directives and the relevant transitional period when legacy devices can be placed on the market or put into service beyond May 26, 2024.

Namely, certificates issued in accordance with Directives 90/385/EEC and 93/42/EEC from May 25, 2017, that were still valid on May 26, 2021, remain valid until:

• December 31, 2027, for all class III devices, and for class IIb implantable devices except sutures, staples, dental fillings, dental braces, dental crowns, screws, wedges, plates, wires, pins, clips, and connectors;
• December 31, 2028, for class IIb devices other than those covered under the previous point, for class IIa devices, and for class I devices placed on the market in sterile condition or that have a measuring function.^[4]

This extension is automatic (subject to the additional requirements below) for certificates that have not expired on the effective date of the Regulation (March 20, 2023). Conversely, for certificates valid on March 26, 2021, but expired on March 20, 2023, the extension is subject to one of the following conditions:

1. prior to the expiration date of the certificate, the manufacturer and a notified body have signed a written agreement^[5] for compliance assessment of the device covered by the expired certificate or a device intended to replace that device;
2. a competent authority of a Member State has waived the applicable compliance assessment procedure in accordance with Article 59, par. 1 of the MDR or has required the manufacturer, in accordance with Article 97, par. 1 of the MDR, to carry out the applicable compliance assessment procedure.^[6]

In both cases (i.e., when the extension is automatic and when it is subject to the conditions above), the device may be placed on the market or put into service, as the case may be, until December 31, 2027, or December 31, 2028, provided that the following additional requirements are met: (a) the device continues to comply with Directive 90/385/EEC or Directive 93/42/EEC; (b) there are no significant changes in the design and intended purpose; (c) the device does not pose unacceptable risk to the health or safety of patients, users, or other persons, nor does it threaten other aspects of public health protection; (d) no later than May 26, 2024, the manufacturer has implemented a quality management system in accordance with Article 10, par. 9 of the MDR; (e) no later than May 26, 2024, the manufacturer or the authorized representative has filed a formal application with a notified body for compliance assessment^[7] and, no later than September 26, 2024, the notified body and the manufacturer have signed a written agreement^[8] in accordance with the MDR.^[9]

Finally, devices for which the compliance assessment procedure pursuant to Directive 93/42/EEC did not require the involvement of a notified body, for which a statement of compliance was drawn up prior to May 26, 2021, and for which the MDR requires the involvement of a notified body may be placed on the market or put into service until December 31, 2028, provided that the requirements in the previous paragraph are met.

The new transitional period for class III devices

The Regulation also introduces a new transitional period for custom-made implantable class III devices.

Such devices may be placed on the market or put into service through May 26, 2026, without a certificate issued by a notified body, provided that, by May 26, 2024, the manufacturer or the authorized representative submits a formal application to a notified body for compliance assessment^[10] (in accordance with Annex VII, Section 4.3, first paragraph) and, by September 26, 2024, the notified body and the manufacturer sign a written agreement in accordance with the MDR.^[11]

Elimination of the sell-off period

As noted above, the Regulation eliminates what was known as the “sell-off” period for both medical devices and in vitro diagnostic medical devices.^[12] This was the latest date for making available devices placed on the market before or during the transitional period that are still in the supply chain when that period is over. The aim is to avoid unnecessary disposal of safe medical devices that are already on the market but not yet with end users, thereby preventing shortages of such devices.

Thus, once legacy devices regulated by the MDR and the IVDR are on the market within the timeframe of the new transitional period, these products can be marketed without time restrictions.

[1] As amended by Regulation (EU) 2020/561.

[2] Based on the results of a survey among notified bodies conducted end of November/beginning of December 2022, reported in the amendment proposal of the European Commission.

[3] Article 120, par. 4 of the MDR and Article 110, par. 4 of the IVDR.

[4] According to point no. 4 of the Q&A on the Regulation, the classification rules in Annex VIII to the MDR apply in assessing the risk class of the device. In certain cases, where the classification rules of the MDR indicate a different risk class, the device risk class indicated on the certificate may differ from the risk class that determines the end date of the transitional period. However, when during the transitional period a device’s risk class is needed to determine applicable MDR requirements (e.g., in relation to PSUR), the device’s class is the one established in accordance with the MDD classification rules (see MDCG 2021-25).

[5] In accordance with the MDR, Annex VII, Section 4.3, second subparagraph.

[6] Even if the national waiver is limited in time or the manufacturer is required to carry out the compliance assessment procedure within a given period of time, the device enjoys the full transitional period until December 31, 2027, or December 31, 2028, as applicable (point no. 6, Q&A on the Regulation).

[7] In accordance with the MDR, Annex VII, Section 4.3, first subparagraph.

[8] According to point no. 12 of the Q&A on the Regulation, if the manufacturer and the notified body entered into a written agreement prior to March 20, 2023 (which may be necessary in the case of certificates issued under the directives that expired before March 20, 2023), a new agreement is not needed and the requirement set out in par. 3c, lett. e), of the new Art. 120 MDR is considered fulfilled.

[9] Annex VII, Section 4.3, second subparagraph. With regard to the elements required for filing the application for compliance assessment or for the written agreement with the notified body, see also points nos. 8 and 9 of the Q&A on the Regulation.

[10] In accordance with Annex VII, Section 4.3, first paragraph.

[11] Annex VII, Section 4.3, second paragraph.

[12] Article 1, par. 1, lett. C, and Article 2, par. 1 of the Regulation.