EU Commission Implementing Regulation (EU) 2023/1194

Authored by DENISE MCDERMOTT, senior Regulatory Compliance Specialist, Compliance & Risks

Commission Implementing Regulation (EU) 2023/1194

Commission Implementing Regulation (EU) 2023/1194, amending Implementing Regulation (EU) 2022/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745, was published on 21 June 2023 in the Official Journal of the European Union.

These transitional provisions allow manufacturers of products categorized under Annex XVI additional time to comply with the requirements under Regulation (EU) 2017/745. Annex XVI to Regulation (EU) 2017/745 includes, among others products such as contact lenses or other items intended to be introduced into or onto the eye, equipment for liposuction, lipolysis or lipoplasty, and certain equipment intended for brain stimulation.

Clinical Investigations

The timeline for products where a clinical investigation is planned in paragraph 1 of Article 2 of Commission Implementing Regulation (EU) 2023/1194, was amended to replace the date 22 June 2028 with the date 31 December 2029. This means that 31 December 2029 will be the end of the transition period for a product which requires a clinical investigation.

With regards to notified body agreements, the regulation will now read as follows; “By way of derogation from the first subparagraph, from 1 January 2028 until 31 December 2029, a product that meets the conditions laid down in that subparagraph may only be placed on the market or put into service, if a written agreement for the performance of the conformity assessment has been signed by the notified body and the manufacturer in accordance with Section 4.3, second subparagraph, of Annex VII to Regulation (EU) 2017/745”. This means that the deadline to have a written agreement in place with a notified body for these products is 1 January 2028.

In the third subparagraph of Article 2, the date 22 June 2026 is replaced by 31 December 2027. Therefore, from 23 December 2024 until 31 December 2027, a product that meets certain conditions may only be placed on the market or put into service, if the sponsor has started the clinical investigation.

Products That Do Not Require A Clinical Investigation

With regards to products that do not require a clinical investigation, in the first subparagraph of paragraph 2, the date 22 June 2025 is replaced by 31 December 2028. This means the end of the transition period is now 31 December 2028, if there is no need for a clinical investigation.

With regards to notified body agreements, the regulation will now state the following; “By way of derogation from the first subparagraph, from 1 January 2027 until 31 December 2028, a product that meets the conditions laid down in that subparagraph may only be placed on the market or put into service, if a written agreement for the performance of the conformity assessment has been signed by the notified body and the manufacturer in accordance with Section 4.3, second subparagraph, of Annex VII to Regulation (EU) 2017/745”. This means that manufacturers now have a deadline of 1 January 2027 to sign an agreement with a notified body.

CE Certificates

According to Commission Implementing Regulation (EU) 2023/1194, with regards to products with a valid CE certificate, in paragraph 3 the following will be added:

“A product which was covered by a certificate issued by a notified body in accordance with Directive 93/42/EEC that expired after 26 May 2021 and before 20 March 2023, and for which the conditions laid down in Article 120(2), second subparagraph, point (a) or (b), of Regulation (EU) 2017/745 are not met, may be placed on the market or put into service until the dates laid down in Article 120(3a) of Regulation (EU) 2017/745, also after the expiry of the certificate, provided that the conditions set out in Article 120 (3c), (3d) and (3e), of Regulation (EU) 2017/745 are met”.

This means that for such a product which was covered by a certificate issued by a notified body in accordance with Directive 93/42/EEC, and conditions in Article 120(2), second subparagraph, point (a) or (b) are not met, may be placed on the market or put into service until 31 December 2027 for class III devices and for class IIb implantable devices, and 31 December 2028 for class IIb devices, class IIa devices, and class I devices placed on the market in sterile condition or having a measuring function. The transitional timelines are dependent on compliance with conditions set out in Article 120 (3c, 3d, 3e), of Regulation (EU) 2017/745 including that no significant changes occur to the design and intended purpose.

This Regulation applies from 22 June 2023, and is binding in its entirety and directly applicable in all Member States.

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