Important Changes Impacting Manufacturers of Products without an Intended Medical Purpose
On December 1, 2022, the European Commission published common specifications under Annex XVI of the Medical Devices Regulation (MDR). Annex XVI sets out the requirements for groups of products without an intended medical purpose.
Per Article 2 (71) ‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system. Manufacturers must comply with common specifications unless they can duly justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent.
Common specifications have long been in place in the high-risk in-vitro diagnostics world under the term Common Technical Specification. Common Specifications will offer a pathway for manufactures of Annex XVI to comply with requirements for risk management, production and post-production activities as well as post production information to be considered, information for safety and various technical requirements and/or limitations. Specific requirements are outlined for:
contact lenses,
products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy such as breast implants,
dermal or mucous membrane filling, equipment for liposuction, lipolysis or lipoplasty, lasers and intense pulsed light equipment
and brain stimulation devices that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity.
Transitional provisions to comply with the new regulation are outlined in Article 2 of the legislation and the Regulation itself shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. The full text is available on the Comitology Register of the European Commission Website.
It is important that manufacturers are aware of publications dates as many of the deadlines have passed or are quickly approaching. This is particularly challenging for manufacturers that have previously only been considered in cosmetic or consumer use regulations. Manufacturers must consider resources and market viability when transitioning to the medical device regulations.
For more information: Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (Text with EEA relevance)