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On June 22, 2023, the Implementing Regulation 2022/2346 of December 1, 2022 comes into effect, establishing the Common Specifications for Products Without Medical Purpose under Regulation (EU) 745/2017.
This means that from that date, products without medical purpose that are part of this Annex XVI of the MDR must comply with the Regulation’s requirements and with what is required by the Common Specifications. Effective date and application according to specific cases 1. IN clinical investigation OR PLANNED to comply with the MDR, AND YES NOTIFIED BODY If legally marketed BEFORE JUNE 22, 2023, and NO significant changes in design or intended purpose occur. They can continue to be marketed UNTIL JUNE 22, 2028. Between December 23, 2024, and June 22, 2026, only products that meet the mentioned conditions and if the sponsor has initiated the investigation can be introduced to the market. Between June 23, 2026, and June 22, 2028, only products that meet the mentioned conditions and if a contract has been signed with a NB for conformity can be introduced to the market. 2. NO clinical investigation, but YES NOTIFIED BODY If legally marketed BEFORE JUNE 22, 2023, and NO significant changes in design or intended purpose occur. They can continue to be marketed UNTIL JUNE 22, 2025. They must sign an agreement with the NB between September 22, 2023, and June 22, 2025. 3. Products to which the common specifications apply AND HAVE A CERTIFICATE ISSUED BY A NB IN ACCORDANCE WITH DIRECTIVE 93/42/EEC may be introduced to the market:
UNTIL JUNE 22, 2028 (INVESTIGATION + NB) UNTIL JUNE 22, 2025 (NO INVESTIGATION + NB) Even if the certificate expires, IF THEY WERE MARKETED BEFORE JUNE 2023. If the certificate expires AFTER MAY 2021 until the dates they can be introduced to the market, compliance with requirements must be monitored with a signed agreement with the designated NB. Product groups of Annex XVI of the MDR
Annex XVI of the MDR refers to 6 product groups:
1. Products intended to be wholly or partially introduced into the human body through surgical invasive means for the purpose of modifying anatomy or fixing body parts.
Not applicable to:
Products for tattoos and piercings. Products intended to be introduced into the body through surgical invasive means for the purpose of fixing body parts. Active implantable products. 3. Equipment intended for use in reducing, removing, or destroying adipose tissue, such as liposuction, lipolysis, or lipoplasty equipment.
They must be classified as class IIb products.
Not applicable to:
Active implantable products. 5. Equipment that emits high-intensity electromagnetic radiation (such as infrared, visible light, and ultraviolet) intended for use on the human body, including coherent and non-coherent, monochromatic, or broad-spectrum sources, such as lasers and intense pulsed light equipment for skin rejuvenation, tattoo removal, hair removal, or other dermal treatments.
It is necessary that: