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News

By Regulation (EU) 2022/112, the EU has amended the transition provisions for certain in-vitro diagnostic medical devices and postponed the date of application for „in-house devices” to 26 May 2028....

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Recognition in Taiwan

Just in time with respect to the date of application of the third generation of the Technical Cooperation Programme on Exchange of Medical Device Quality Management System Regulation and ISO 13485...

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The establishment of the company mdc medical device certification GmbH was commercially registered 25 years ago on December 10, 1996.

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Legacy Devices

Dear Madam or Sir!

As of 2021-05-26, Directive 93/42/EEC on medical devices (hereinafter MDD) was withdrawn and thus became invalid. Consequently, according to Article 120 (1) of Regulation (EU)...

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On 14.10.2021, the EU Commission published a proposal for the extension of transitional periods for the IVDR. According to this proposal, the start of application on 26.05.2022 is to remain, but...

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The implementation of the EUDAMED database continues to make good progress, and existing specifications are being further elaborated and adapted accordingly.

The timelines for the mandatory...

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The Competent Authority for medical devices in Taiwan TFDA has extended the transition period for the application of the new „Technical Cooperation Programme“ for an abbreviated market access to...

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