On June 21, 2023, the Official Journal of the European Union published the Implementing Regulation (EU) 2023/1194 amending the transitional provisions laid down in Implementing Regulation (EU) 2022/2346 for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 (MDR). This document has been adopted to align the transitional provisions set out in the Common Specifications (EU) 2022/2346 to those set out in the amended MDR. In response to this, on September 26th, 2023, the EU published a new Q&A document to help manufacturers and other actors understand the transitional provisions for such devices covered by Annex XVI.
It is clear that manufacturers whose devices are now covered by Annex XVI will be keenly interested in this document, particularly those whose products were not covered by the medical device directive nor the cosmetic regulations, needing answers on how the transitional provision apply.
As a small reminder, the Annex XIV products refer to devices without an intended medical purpose and while not having a medical intended purpose, these devices are still within the scope of the MDR. Annex XVI encompasses devices such as:
- Contact lenses or other items intended to be introduced into or onto the eye.
- 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.
- 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.
- Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.
- 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.
- 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.
It is important to note that this list can be amended at any time by the EU Commission to encompass a wider range of devices.
Taking a closer look at the Q&A, the first 2 questions of the Q&A document highlight that the Common specifications and hence, MDR, are applicable to Annex XVI products as from 22nd June 2023.
The document also highlights the transitional periods for the following situations.
- Transitional Period set out in the Common Specifications for Products for which a notified body is involved in the conformity assessment and the manufacturer decides to perform a clinical investigation.
- Transitional Periods set out in the Common Specifications for Products for which a notified body is involved in the conformity assessment and the manufacturer decides not to perform a clinical investigation.
- Transitional Periods set out in the MDR for Annex XVI Products covered by an MDD certificate.
- Transitional Period set out in the Common Specifications for Annex XVI products covered by an MDD certificate.
- Transitional Period set out in the Common Specifications for Annex XVI products covered by an MDD certificate were applicable before 22 June 2023
- Transitional Period for Products incorporating a medicinal product.
- Transitional Period for Dual purpose devices.
Question 11 of the Q&A describes how manufacturers can demonstrate that their products benefit from the transitional periods. As already seen before, manufacturers can demonstrate that the conditions for benefitting from the transitional provisions are fulfilled by means of a self-declaration which should contain some important information such as the devices covered. The declaration could be based on a harmonised template and additional evidence in the form of a confirmation letter issued by the Notified Body can be used to confirm that an application has been lodged and signed, further adding weight to the manufacturer’s declaration.
Lastly, the Q&A clarifies if notified bodies can issue certificates for Annex XVI products under the MDR during the transitional periods. The document states that, yes, notified bodies can in fact issue certificates for Annex XVI products under the MDR as from 22nd June 2023.
The Q&A document can be accessed using the following link
