Since 28 May 2026, the use of the first four EUDAMED modules has become officially mandatory: Actor Registration UDI/Devices Notified Bodies & Certificates Market Surveillance This marks a new phase of regulatory compliance for all economic operators in the European medical device industry. Particular attention should be paid to the UDI/Devices module, as the applicable…

As of September 1, 2025, the European co-operation for Accreditation (EA) has officially released the combined MLA mark (or “EA-Mark” for short). The EA mark highlights the international recognition of your certification. Within Europe, it also carries a formal obligation for recognition. As an accredited certification body, we are pleased to inform you that, effective…

For the past ten years, our Vienna branch has been an integral part of Austria’s medical technology landscape. What began as a strategic expansion to provide local expertise and support for our customers has evolved into a significant and indispensable location serving the entire German-speaking region. For a decade, we have been making an important…

From May 5 to 7, 2026, Stuttgart will once again become the vibrant hub of the European MedTech industry. Following the success of 2024, MedtecLIVE 2026 will open its doors again – and we are right in the middle of it as an exhibitor! Visit us at our booth We warmly invite you to meet…

We are pleased to announce that mdc medical device certification GmbH, together with five other European Notified Bodies, successfully signed the TCP III agreement, thereby securing the renewal of our designation in Taiwan. This renewed designation enables us to continue supporting manufacturers in accessing the Taiwanese market and underlines our commitment to internationally harmonized conformity…

We cordially invite you to visit us at our first Swiss Medtech Expo from September 9 to 10, 2025, in Lucerne! Our team members Harald Rentschler (Managing Director) and Oliver Gindlhumer (Deputy Head of Medical Devices, Auditor and Expert) will be waiting for you at our booth B 2057 in Hall 2 (joint booth Medical…

Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) provide for regular unannounced audits – as already established under Directives 93/42/EEC (MDD) and 98/79/EC (IVDD). This also applies to the “appropriate monitoring” of legacy devices in accordance with Article 120 MDR or Article 110 IVDR, which are still placed on the market under the respective Directive. To…

Our Tuttlingen branch has a new home: as of this week, we can be found in the Drei-Kronen-Hof in the centre of Tuttlingen – just a few minutes’ walk from our previous location on Rathausstraße. The Drei-Kronen-Hof offers the ideal opportunity to stay rooted in the region while continuing to grow. With 15 modern workspaces,…

At our February information sessions on the transition from the IVDD to the IVDR, we had in-depth discussions about common errors in the submission of technical documentation. Many manufacturers face similar challenges – which is why we, as a Notified Body, have now published the most frequent non-conformities on our website. What can you expect?…

With the publication of revision 4 of the MDCG 2022-16 “Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746“ in March of this year, amongst other SARS-CoV-2 devices were re-classified. In summary, SARS-CoV-2 devices for professional use are classified as class B, whereas SARS-CoV-2 devices intended for lay use are…