Common Specifications for Annex XVI Products

On 1 December 2022, the European Commission published a Commission Implementing Regulation which lays down “common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745”. This regulation will enter into force 20 days after its publication in the Official Journal of the European Union (OJEU) and begin to apply 6 months after entry into force (except for Article 2(3) which applies from entry into force). In fact, it’s good to note that this document will at that time be updated with the relevant dates of application (DOA), entry into force, and transitional provisions.

The purpose of these Common Specifications (CS) is to allow manufacturers of Annex XVI products to demonstrate conformity to the General Safety and Performance Requirements on risk management as set out in Annex I of the EU MDR (specifically Sections 1, 2-5, 8 and 9). Annex XVI products in conformity with these CS will be presumed to be in conformity with the requirements of the EU MDR covered by the CS.

The document consists of 3 pages of preamble (an important section which should not be overlooked!), 3 pages of main implementing regulation, and around 35 pages split over 7 Annexes; Annex I being for general requirements of Annex XVI products, and the remaining Annexes for each specific Annex XVI product including:

Annex II: Contact lenses or other items intended to be introduced into or onto the eye. [Annex XVI p1]

Annex III: Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings. [Annex XVI p2]

Annex IV: Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing. [Annex XVI p3]

Annex V: Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty. [Annex XVI p4]

Annex VI: High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment. [Annex XVI p5]

Annex VII: Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain. [Annex XVI p6]

Therefore, in addition to the requirements laid down in the EU MDR, Annex XVI products will be expected to also meet the conditions and requirements as indicated within this CS. Each Annex presents product-specific requirements to be met or taken into consideration within the technical documentation.

For each product, we would suggest preparing the technical documentation as required by the EU MDR but taking into consideration these additional requirements within the CS. It would be good practice to develop a “CS Conformity Document” in which you indicate how you demonstrate conformity with the CS, giving reference to the applicable evidence (similar to how one would complete a GSPR checklist).

Transitional Provisions

The transitional provisions for the application of the CS can be a complicated read, to say the least. We tried our best to simplify whenever possible in this section.

Annex XVI products which intend to generate clinical data for the clinical evaluation through clinical investigations and which will require Notified Body intervention.

Such products will be allowed to continue being placed on the EU market or put into service for 5 years following the date of application of this Implementing Regulation if the following conditions are met:

  1. the product was already lawfully marketed in the Union before the DOA and continues to comply with the requirements of Union and national law that were applicable to it before the DOA;
  2. there are no significant changes in the design and intended purpose of the product.

In addition to this, the following shall also apply:

From 12 months until 18 months after the DOA, products eligible for these transitional provisions may only be placed on the market if they have received from the Member State concerned a notification conforming that the application for clinical investigation is complete and that the clinical investigation falls within the scope of the EU MDR.

From 18 months and 1 day until 3 years after the DOA, products meeting the above criteria will only be allowed to be placed on the market or put into service if the sponsor has started the clinical investigation.

From 3 years and 1 day until 5 years after the DOA, products meeting the above conditions 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.

Annex XVI products which do not intend to perform clinical investigations and which will require Notified Body intervention.

Such products will be allowed to continue being placed on the EU market or put into service for 2 years following the date of application of this Implementing Regulation if the following conditions are met:

  1. the product was already lawfully marketed in the Union before the DOA and continues to comply with the requirements of Union and national law that were applicable to it before the DOA;
  2. there are no significant changes in the design and intended purpose of the product.

From 3 months until 2 years after the DOA, products meeting the above conditions 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.

Annex XVI products which are covered by a certificate issue by a Notified Body in accordance with Directive 93/42/EEC (MDD).

Such products will be allowed to continue being placed on the EU market or put into service for either 2 or 5 years (depending on the previous paragraphs) following the date of application of this Implementing Regulation and after the expiry of that certificate, if the following conditions are met:

  1. the product was already lawfully marketed in the Union before the DOA and continues to comply with the requirements of Directive 93/42/EEC, except for the requirement to be covered by a valid certificate issued by a notified body where the certificate expires after 26 May 2021;
  2. there are no significant changes in the design and intended purpose of the product;
  3. after the expiry date of the certificate issued by a notified body in accordance with Directive 93/42/EEC, the appropriate surveillance of the compliance with the conditions referred to in points (a) and (b) of this paragraph is ensured by way of a written agreement signed by the notified body that has issued the certificate in accordance with Directive 93/42/EEC or a notified body designated in accordance with Regulation (EU) 2017/745 and the manufacturer.

You can read the full text here: Implementing Regulation