December 10, 2021The establishment of the company mdc medical device certification GmbH was commercially registered 25 years ago on December 10, 1996.…- November 15, 2021Dear Madam or Sir! As of 2021-05-26, Directive 93/42/EEC on medical devices (hereinafter MDD) was withdrawn and thus became invalid.…
- October 18, 2021On 14.10.2021, the EU Commission published a proposal for the extension of transitional periods for the IVDR. According to this…
- October 11, 2021The implementation of the EUDAMED database continues to make good progress, and existing specifications are being further elaborated and adapted…
- August 3, 2021The Competent Authority for medical devices in Taiwan TFDA has extended the transition period for the application of the new…
- May 31, 2021The Regulation (EU) 2017/745 (MDR) describes in Article 87 for all manufacturers of medical devices binding requirements for the interpretation…
- May 27, 2021As of today (2021-05-26), Regulation (EU) 2017/745 on medical devices (MDR) represents the applicable legal framework for medical devices. This…
- May 18, 2021As of 2021-05-26, the Medical Device Directive 93/42/EEC (MDD) and the Active Implantable Medical Device Directive 90/385/EEC (AIMDD) are history.…
- March 8, 2021The new MDR will replace the currently valid medical device directives (MDD and AIMDD) on May 26, 2021. A corresponding…
- January 28, 2021A very eventful year lies behind us. The Corona pandemic had a massive impact on all areas of life and…
