Confirmation of receipt of a formal application and conclusion of a written agreement within the framework of Regulation (EU) 2023/607 amending Regulation (EU) 2017/745 as regards the transitional provisions for certain medical devices

Berlin Cert Prüfstelle für Medizinprodukte GmbH, an official testing body for medical devices, confirms that the application for the Luxxamed HD2000+, a Class IIa medical device, has been received in accordance with EU Regulation 2023/607. This Regulation concerns the transitional provisions for certain medical devices and allows the LuXXaMed HD2000+, which was previously certified under older EU Directives, to remain on the market.

The LuXXaMed HD2000+ is a device for the treatment of acute and chronic pain using microcurrent and light therapy. It falls within Class IIa and therefore requires official certification by a Notified Body.

The products concerned, including the LuXXaMed HD2000+, are covered by an agreement between us and the manufacturer. This confirmation ensures that the application was submitted in good time, so that the HD2000+ remains compliant and can continue to be used safely on the market.

Transitional periods for the LuXXaMed HD2000+:

• Until 31 December 2028: For the LuXXaMed HD2000+ as a Class IIa medical device subject to the new provisions of EU Regulation 2017/745 (MDR).

These periods apply provided that the manufacturer continues to meet all relevant legal requirements and the LuXXaMed HD2000+ complies with the specified safety and performance requirements.