Regulation of Products without Intended Medical Purpose in Finland

1. Definition and Scope

Products without an intended medical purpose but similar to medical devices in functioning and risk profile are regulated under Regulation (EU) 2017/745 (MDR) Annex XVI. These include items like coloured contact lenses, dermal fillers, and laser equipment for cosmetic use. Source: Fimea Products without a Medical Purpose Page https://fimea.fi/en/medical-devices/products-without-a-medical-purpose

The six groups listed in Annex XVI are:

1. Contact lenses or other items introduced into or onto the eye.
2. Products introduced into the body surgically for anatomy modification or fixation (excluding tattooing/piercings).
3. Facial or dermal/mucous membrane fillers (excluding tattooing).
4. Equipment to reduce/remove/destroy adipose tissue (e.g., liposuction, cryolipolysis).
5. High-intensity electromagnetic radiation equipment for skin treatments (e.g., lasers, IPL for hair/tattoo removal).
6. Equipment for brain stimulation using electrical/magnetic fields. Source: Fimea Products without a Medical Purpose Page https://fimea.fi/en/medical-devices/products-without-a-medical-purpose

2. Applicable Requirements

MDR requirements apply to manufacture, import, distribution, and marketing. They do not apply to products already in service. Source: Fimea Products without a Medical Purpose Page https://fimea.fi/en/medical-devices/products-without-a-medical-purpose

3. Conformity Assessment

Manufacturers define intended purpose, conduct conformity assessment, and apply CE marking with a declaration of conformity. Source: Fimea Products without a Medical Purpose Page https://fimea.fi/en/medical-devices/products-without-a-medical-purpose

4. Clinical Evaluation and Investigations

Clinical evaluation must follow common specifications, using performance/safety data from post-market surveillance and, where needed, specific clinical investigations. Equivalence justification may suffice; otherwise, investigations are required (following MDR clinical investigation rules). Source: Fimea Products without a Medical Purpose Page https://fimea.fi/en/medical-devices/products-without-a-medical-purpose

5. Common Specifications and Transitional Provisions

Common specifications adopted via Implementing Regulation (EU) 2022/2346, in force 22 December 2022, mainly applicable from 23 June 2023. Transitional provisions allow market placement/service until 22 June 2028 if lawfully and significant changes absent. Reclassification of active products via (EU) 2022/2347. Source: Fimea Products without a Medical Purpose Page https://fimea.fi/en/medical-devices/products-without-a-medical-purpose