Products without an intended medical purpose: EU clarifies conditions
Published on 20th Dec 2022
Non-medical product manufacturers have limited time to prepare for new risk management and clinical data obligations
An implementing regulation (EU) 2022/2346 on products without an intended medical purpose was published on 2 December 2022. The new regulation lays down eagerly awaited common specifications (CS) required for a specific category of "non-medical products" captured by regulation (EU) 2017/745 on medical devices (MDR). It impacts a broad range of sectors spanning the cosmetics, wellness, hardware, gaming and tech industries.
What are common specifications?
CS are a set of technical and clinical requirements, other than a standard, that provide a means of complying with the legal obligations applicable to a device, a process or a system.
Why are they needed?
While the MDR applies almost in full in the EU – conditional on a few transitional provisions – since 26 May 2021 to devices, accessories and clinical investigations, so far groups of products without an intended medical purpose (also called "annex XVI products") are not yet subject to it. This position will change on 22 June 2023, when annex XVI products will have to comply with both the MDR and the new CS.
Which products are covered by the new CS?
Groups of products without an intended medical purpose are listed in annex XVI of the MDR. This list remains unchanged by the new CS. However, regulation (EU) 2022/2346 introduces clarifications as to the applicability of the MDR to a number of those products groups, such as sunbeds and equipment using infrared optical radiation to warm the body and brain stimulation equipment.
Which aspects of product conformity does the CS regulate?
Under the MDR, the CS are intended to address risk management and, where applicable, clinical evaluation regarding safety.
With what do the CS' risk management principles align?
The CS' risk management principles intentionally aim for alignment with ISO 14971:2019 on account of the fact that the regulation of medical devices and non-medical products should be based on the same harmonised principles.
Compliance with those principles provides a presumption of conformity with selected provisions of the MDR's annex I on general safety and performance requirements (GSPR). The CS assign a significant number of legal responsibilities, based on ISO 14971:2019, to manufacturers, their senior management and qualified personnel. They also introduce the concept of "consumers" (rather than "patients") to the regulatory framework.
Manufacturers of non-medical products are bound by numerous safety information requirements. These are not limited to the instructions for use or the label (which should both bear some mandatory language). They also extend to "other means" such as integration in the device itself and availability in the public domain. Compliance with those requirement supports not only the manufacturer's regulatory strategy but mitigates product liability risks. User training requirements apply for certain types of products. In terms of claims, any clinical benefit claim or statement must be avoided if the device is solely or partly intended for a non-medical purpose.
What is required of the clinical evaluation of safety?
For annex XVI products, the general MDR requirement to demonstrate a "clinical benefit" should be
understood as a requirement to demonstrate the "performance" of the device; as such, clinical evaluations of the products must be based on relevant data concerning safety. This includes data from a variety of sources: post-market surveillance; post-market clinical follow-up; and specific clinical investigation(s), unless reliance is placed on existing clinical data from an "analogous" medical device (the CS specify what analogous means and the conditions that must be met).
Comparable requirements apply in the post-production phase. However, the CS do not specify how the system to collect and review information from the production and post-production phases should be set up. Once a product is on the market, experience shows economic operators (for example, distributors) and end users (for example, healthcare professionals) may be asked to support manufacturers through agreements or otherwise.
Are there exceptions to the 22 June 2023 deadline?
A number of steps that are required for compliance with the CS cannot be completed in the limited time available before 22 June 2023, including: conformity assessment procedures where a notified body has to be involved, and clinical investigations which must be performed for certain non-medical products to confirm conformity with the relevant GSPR.
New products falling into this category are subject to specific transitional provisions. So are legacy products; that is, non-medical products that were covered by a notified body certificate issued under Directive 93/42/EEC (MDD). In both cases, placing on the market or putting into service may occur until 22 June 2028 (if a clinical investigation and a notified body are required) or until 22 June 2025 (if only a notified body is required).
The CS "grace period" conditions resemble those set out in the MDR (article 120), with additional obligations when clinical investigations must be carried out. Among those conditions, a written agreement for the performance of the conformity assessment must be signed on time by the notified body and the manufacturer. Legacy devices must continue to comply with MDD requirements after June 2023, and the agreement between the manufacturer and its notified body should address the surveillance of compliance with regulatory requirements. Furthermore, no significant changes in the design and intended purpose of the product should occur during the grace period.
Osborne Clarke comment
Manufacturers of non-medical products have limited time to prepare for the ambitious risk management and clinical data obligations imposed by the new CS, including those pertaining to safety information, packs and labelling, clinical investigations, documentation (including contracts) and personnel qualification.
They should be mindful of the general principles applicable to all annex XVI groups (annex I to the implementing regulation) and those that are technology specific (annexes II to VII).
Transitional (grace period) provisions allow for some leeway but experience gained with MDR grace period and "sell-off" strategies showed preparation is not an easy task. All products must be placed on the market or put into service before June 2023 for the deadline extensions to apply. This requires that the manufacturing stage has been completed and that an offer or an agreement for the transfer of ownership, possession or any other property right concerning the product has been made; physical handover of the products is not relevant.
New agreements must be entered into with notified bodies and, where applicable, clinical investigations must be started (and applications filed) on time. Challenges await regulatory and quality professionals as they prepare for the new requirements.