In an important step forward for manufacturers of devices without a medical purpose, the final version of the ‘Implementing Regulation’ containing the common specifications was published on 2 December 2022. Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 can be found here.
Regulation 2022/2346 is intended to fulfill the requirements of the MDR for common specifications for devices without a medical purpose addressing, “at least, application of risk management as set out in the general safety and performance requirements laid down in Annex I to that Regulation and, where necessary, clinical evaluation regarding safety.”
The common specifications are provided in a series of seven (7) annexes. Annex I applies to all devices covered by the Implementing Regulation, while Annexes II to VII provide more product-specific requirements for the different product types and correspond to Sections 2 to 6 of Annex XVI of the MDR.
Annex I Key Points:
- Detailed requirements are provided for risk management processes
- Emphasis on top-level management responsibility for ensuring the risk management process is executed and for ensuring risk acceptability
- Appropriate qualifications and device experience for the risk management team
- Careful consideration of the user category: healthcare professional, lay user with qualification or lay user without qualification
Information for Safety
- “Non-medical purpose” to appear on the label
- User categories to be identified
- No clinical benefit claim or statements are permitted
- Additional ways of providing safety information to be considered
- Readability of information taking into account users and consumers
- Reference to standards and common specifications applied
Annexes II to VII each provide detailed product-specific requirements for risk management and labelling. A detailed review is recommended as some Annexes include specific requirements for clinical data and restrictions in the use of the device. For example, manufacturers of devices such as dermal fillers (Annex III) must include a statement on the label that the device is not to be used in persons who are less than 18 years old.
It is also important to review the scope of each Annex, as certain devices are excluded (see table below).
The Implementing Regulation applies from 22 June 2023. Crucially, given the delay in publishing these common specifications, transitional provisions are provided in Article 2 for various scenarios, included below.
|1. Manufacturer intends to perform/is performing a clinical study to demonstrate compliance|
|Timeline for clinical study
22-Jun-2024 until 22-Dec-2024
23-Dec-2024 until 22-Jun-2026
|Signed agreement for conformity assessment by Notified Body to be in place||
23-Jun-2026 until 22-Jun-2028
|2. Manufacturer does not intend to perform a clinical study to demonstrate compliance|
|Signed agreement for conformity assessment by Notified Body to be in place||22-Sep-2023 until 22 Jun-2023|
|3. Existing CE certificate under the Medical Device Directive (MDD)|
Clinical study planned/ongoing
No clinical study
|Signed agreement with Notified Body in place||Certificate expiry|
Overall, Regulation 2022/2346 provides a much needed extension beyond the MDR deadline of May 2024, at least for devices without a medical purpose. It is particularly interesting to see that it includes an extension for devices that were already subject to certification under the MDD. These devices can continue to be placed on the market after their certificates expire by means of a written agreement between the manufacturer and their Notified Body. This may be the original Notified Body who issued certification or another Notified Body designated under the MDR. .
|Annex I||Risk Management for all Annex XVI devices|
|Annex II||Contact lenses/items introduced into the eye
|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
|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 V||Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.
|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 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.
How Can NAMSA Help?
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies. Our internal teams of medical device regulatory experts communicate with EU entities nearly every day and are the most experienced in industry at accelerating regulatory submissions and approvals for manufacturers. In fact, many of our Associates have previously held positions within these organizations, which provides Clients the benefit of a clearer understanding on how to proactively plan for international requirements and expectations.
To learn about NAMSA’s full suite of Regulatory and Quality services and solutions, including MDR compliance planning, please visit: https://namsa.com/services/regulatory-and-quality-consulting/.
Or, if you are interested in meeting with one of our regulatory experts, please visit: https://namsa.com/namsa-expertise/subject-matter-experts/.
Jane Arnold-Round has 30 years’ experience in the medical device industry working with a broad range of medical device technologies and organisations from start-ups to multinationals. She was a Notified Body reviewer for over 15 years having worked for BSI as a medical device product specialist with particular responsibility for the wound care sector, device-drug combinations medical device utilising animal tissues. A regulatory consultant for 17 years, she joined the medical device consulting team at NAMSA in 2018 and currently serves as a Senior Principal Regulatory Consultant.