随着全球医疗器械贸易的蓬勃发展，欧盟CE认证已成为中国医疗器械企业进入欧洲市场的“通行证”。其中，原医疗器械指令（MDD，93/42/EEC）作为欧盟针对医疗器械的核心法规，虽已被医疗器械 ...

In a recent MD+DI webinar called, “Understanding the EU MDR”, which was sponsored by Accumold, Nelson Laboratories, and Oliver Healthcare Packaging, Dr. Bassil Akra, CEO of Akra Team GmbH, gave ...

PARIS--(BUSINESS WIRE)--DentalMonitoring is proud to announce that the DentalMonitoring Software is now certified under the European Union Medical Device Regulation 2017/745 (EU MDR) and fulfills the ...

The European Union’s Medical Device Regulation (MDR) is a complex regulatory framework created to put in place rules and requirements in how medical devices are designed, manufactured, and marketed.

BEIJING, Dec. 3, 2025 /PRNewswire/ -- Wingderm® announces that its Renuva 1550nm non-ablative fractional laser system has obtained MDR certification in the European Union, marking a significant ...

PARIS--(BUSINESS WIRE)--Regulatory News: CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for ...

Can New Devices be Approved from Single Arm Studies: Use of Real-World Data as an External Control Group or for Propensity Matching or Generating Objective Performance Criteria Receive the the latest ...

Within the EEA, MDD products that have already been placed on the market may continue to be sold or put into service indefinitely unless limited by shelf-life/ expiration date. Selling off to ...

Magstim Passes Compliance with Strict European Union Medical Device Regulations Expanding Magstim Access to Entire EU Marketplace WHITLAND, United Kingdom, May 16, 2025 (GLOBE NEWSWIRE) -- Magstim has ...