Unraveling the New Common Specifications for Annex XVI Devices: 2022/2346 and 2022/2347
In a significant development for the Medical Device Regulation (MDR) landscape, the adoption of the Common Specifications within the Commission Implementing Regulations 2022/2346 and 2022/2347 on 1st of December 2022 marks a pivotal milestone. These specifications establish a definitive basis for the conformity assessment procedure of Annex XVI devices, which have no medical purpose, and relevant documentation to be established by the manufacturers. Prior to this, no Common Specification had been fully enacted, leaving a void in the regulation of these products. This breakthrough finally fills that gap and provides a solid foundation for the evaluation of such devices, ensuring they meet the required safety and performance criteria. Additionally, these specifications bring with them reclassification of certain products, further aligning the regulation with the intended purpose of the devices.
Explanation of Common Specifications (CS) 2022/2346 and 2022/2347
The Commission Implementing Regulations 2022/2346 and 2022/2347, as adopted on December 1st, 2022, set forth Common Specifications for Annex XVI products. The Common Specifications provide rules that govern the design and manufacture of these devices, also stipulating methods for post-market surveillance. Their adoption marks a significant change in the regulation of Annex XVI devices, as it provides the basis for these products that serve no medical purpose to undergo a conformity assessment procedure.
In essence, Annex XVI devices encompass a specific set of products that, although not intended for medical use, interact directly with the human body and thus require certain regulatory oversight.
For both regulations, separate deadlines apply:
- Common Specifications as per 2022/2346: applicable since 22nd June 2023. Article 2(3) applicable since 22nd December 2022
- Reclassification as per 2022/2347: 22nd December 2022
Classification of Annex XVI devices
Annex XVI includes products such as non-corrective contact lenses, equipment used for liposuction, skin resurfacing or rejuvenation equipment, and hair removal or other intense pulsed light (IPL) equipment. Also included is equipment for electromagnetic brain stimulation, mechanical equipment for reducing, removing, or destroying adipose tissue, such as body contouring or slimming, and substances intended for use in vitro and on the body for the purpose of tattooing or enhancing personal appearance. In general, the list of products included in the Annex XVI can be amended by the European Union, either adding further products or removing certain ones.
As per the MDR the classification would follow the stipulated rules as per Annex VIII.
Commission Implementing Regulation 2022/2347 now classifies certain products of Annex XVI into a specific class, regardless of the applicable classification rules as per MDR. This includes:
- high intensity electromagnetic radiation emitting equipment
- intended for the use on the human body for skin treatment à class IIb
- intended for hair removal only à class IIa
- equipment intended to be used to reduce, remove or destroy adipose tissue à class IIb
- 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 à class III
Conformity Assessment Procedure for Devices without a Medical Purpose
The role of Common Specifications (CS) in the conformity assessment cannot be overstated. These CS, as stipulated by the EU’s Medical Device Regulation (MDR), provide a harmonized framework requirements that Annex XVI devices must meet. They serve as a definitive guide for manufacturers, setting the bar for safety and performance that their devices must achieve. Each step of the conformity assessment procedure — from documentation to post-market surveillance — is underpinned by these CS. They ensure that the devices are not only safe and effective for their intended non-medical purpose, but also that they maintain these standards in the face of evolving technologies and user needs. The adoption of common specifications like the 2022/2346 represents a significant milestone, providing a much-needed roadmap for manufacturers in their quest for compliance.
In general, the devices have to follow the same conformity procedures laid down in Article 52 of the MDR as any other Medical Device falling under the MDR, in respect of the individual risk class.
Breakdown of the specific requirements stipulated
Annex I of the Common Specifications as per (EU) 2022/2346 includes general requirements for all products covered in the annexes II to VII of the CS. The topics addressed include:
- Risk management,
- Production and post-production activities
- Information for safety
- Instructions for use
Annexes II to VII of the (EU) 2022/2346 then each include more specific requirements on risk management and information for safety. The annexes address the following product groups:
- Annex II: specifications for certain contact lenses without a medical purpose
- Annex III: specifications for certain 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: specifications for certain 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
- Annex V: specifications for 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 (for example 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
Expected benefits and challenges of CS adoption
The adoption of common specifications within Annex XVI offers many potential benefits. It can reduce the time and cost associated with regulatory compliance, while also ensuring that all medical devices and non-medical devices mimicking a medical device are designed to meet rigorous safety and performance standards. Additionally, CS adoption promotes collaboration between manufacturers and notified bodies, which helps foster a better implementation of the MDR requirements.
However, with these benefits come a few challenges. Transitioning to the new regulations might be a daunting task for manufacturers who have previously operated without such stringent guidelines. Adjusting to the new requirements could necessitate significant alterations in the design, testing, and production processes of Annex XVI devices. Additionally, the timeframe for achieving conformity with the CS could be a potential hurdle, particularly for smaller manufacturers. Yet, despite these challenges, the overall benefits of enhanced user safety and increased trust in these products underscore the importance and necessity of the CS adoption.
Overall, the adoption of common specifications within Annex XVI is an important step towards strengthening the safety of medical devices and improving compliance with MDR regulations. By working together and leveraging the benefits offered by CS adoption, manufacturers can ensure that their products are designed to meet the highest standards of safety and performance.
Furthermore, the harmonization process enhances transparency and predictability in the marketplace. With every manufacturer following the same guidelines, there’s a clearer understanding of what constitutes compliance. The introduction of the CS, therefore, not only strengthens consumer faith in Annex XVI devices but also fosters an environment of fairness, innovation, and safety in the medical device market.
Does your product fall under Annex XVI? Are you new to the MedTech world? Reach out to us, we will help you establishing the relevant understanding of the requirements and the documentation needed for your products.
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.