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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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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 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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The Regulation (EU) 2017/745 (MDR) describes in Article 87 for all manufacturers of medical devices binding requirements for the interpretation of the reporting obligations and harmonized timelines...

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As of today (2021-05-26), Regulation (EU) 2017/745 on medical devices (MDR) represents the applicable legal framework for medical devices. This is supplemented by national laws (e.g. in Germany the...

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