Ensure continued marketability of Annex XVI devices – time is flying!

It is well known that the Regulation (EU) 2017/745 intended for medical devices widened up its scope to include a new group of devices defined as “products without an intended medical purpose”. Esthetically refining products such as contact lenses, dermal filler and liposuction devices are prominent examples of “products without a specific medical purpose” that are covered by Annex XVI of the Regulation (EU) 2017/745.

In line with Article 1, the Regulation (EU) 2017/745 got fully applicable with the date of application of the Common Specifications for Annex XVI products as indicated in Regulation (EU) 2022/2346 and the amending Regulation (EU) 2023/1194. This was June 22, 2023.

For devices that nowadays fall under Annex XVI, different timelines are foreseen depending on how the products were marketed prior to the application of the Regulation (EU) 2017/745 and the requirement to involve a Notified Body.

Applicable deadlines!

Legacy devices, previously certified under provisions of the Directive 93/42/EC, that are now Annex XVI products, can benefit from transitional timelines if the well-known prerequisites identified in Article 120 of the Regulation (EU) 2017/745 amended by Regulation (EU) 2023/607 are met:

• Class III and Class IIb implantables (except WET devices such as sutures, staples, wedges, plates, etc.): December 31, 2027
• Class IIb, Class IIa, Class Is, Class Im and Class I products that require the involvement of a Notified Body: December 31, 2028
• Implantable custom-made Class III products: May 26, 2026

For products lawfully marketed in line with European Union requirements (e.g., marked by CE for electrical equipment) and national law, but not certified under the Directive 93/42/EC for medical devices previously, extended timelines may apply depending on the product classification.

Class I Annex XVI products must comply with the Regulation (EU) 2017/745 upon the date of application of the Regulation (EU) 2022/2346 and Regulation (EU) 2023/1194: May 22, 2023

For Class IIa, Class IIb and Class III products lawfully marketed in line with European Union requirements and national law without an MDD certificate, extended timelines apply. To take advantage of these timelines, Regulation (EU) 2022/2346 and Regulation (EU) 2023/1194 outline requirements that must be fulfilled.

Clinical investigations may turn the scale!

Two principal scenarios are described. To identify the correct timeline for the legally marketability of your device without an intended medical purpose, the necessity to raise additional own clinical data to assess safety, performance, acceptability of side-effects and the benefit-risk ratio must be evaluated.

Scenario 1:

Sufficiency of clinical data was concluded, and no clinical investigation is planned. These Annex XVI devices can be marketed until December 31, 2028.

Scenario 2:

Clinical data was not deemed sufficient to fulfill relevant General Safety and Performance Requirements (GSPRs) according to Annex I, MDR. To overcome clinical data gaps, clinical evidence must be raised.

As the collection of clinical data is challenging, the legislator has established an extended transition period: December 31, 2029

In other words, to benefit from an even more extended timeline, the execution of a clinical investigation of the product lawfully marketed earlier is the key.

Tight deadline ahead to benefit from extended transition period!

Under consideration of the prerequisites identified above, a clinical investigation is thought to be covered by Article 62 and Annex XV of the Regulation (EU) 2017/745 (no CE-certified products allowed). This refers to clinical investigations conducted to support safety / performance of the product and to demonstrate compliance with applicable GSPRs. The execution of a clinical investigation of Annex XVI products follows a structured approach predefined in the Regulation (EU) 2022/2346 and Regulation (EU) 2023/1194 with strict time frames the manufacturer must adhere to:

• An application for a clinical investigation must be submitted, completed and confirmed by the involved Member State to market the device from June 22, 2024 – December 22, 2024.
• Subsequently, to cover the period from December 23, 2024 – December 31, 2027, the clinical investigation must be initiated, executed and completed.
• Finally, a written agreement regarding the conformity assessment procedure[MF1] must be concluded with the notified body to enable market access of the product from January 1, 2028 to December 31, 2029.

Annex XVI devices MDR requirements and deadlines

Have you already assessed whether your readily available clinical data set is suitable to confirm compliance with applicable GSPRs? Which timeline is yours?

Get in touch with our Experts!

In case uncertainties regarding the sufficiency of clinical data exist, we can help you analyzing your clinical evidence and identify potential gaps. To gather new clinical data, we are happy to share our knowledge regarding planning, design and execution of clinical investigations. We can also offer access to our network of Clinical Research Organizations.