Knowledge & Resources

Swissmedic has performed inspections at class 1 manufacturers within Switzerland. The result is impressive, but not surprising due to our experience as Authorised Representative in EU, Switzerland and UK. During our onboarding process EUMEDIQ, we check not only completeness of Technical Documentation of our customer, we also do a plausibility check in order to estimate […]

In December 2022, the European Commission published the new directive (EU) 2022/2555 on measures for a common level of cybersecurity across the Union. This led to the amendment of the regulation (EU) 910/2014 on electronic identification and trust services for electronic transactions in the internal market (also known as eIDAS regulation) and repeals the NIS

BREAKING NEWS – EUMEDIQ Ltd. has opened its office in London! EUMEDIQ is now providing UK, EU and Swiss Authorised Representative Services next to Consulting (MDR, IVDR, GDPR and ISO 27001 and ISO 13485) and Auditing Services. Further benefits: More wins with maximum efficiency Your qualified partner to reach your target markets High degree of automation and

Medical device startups are mainly combining latest technologies (i.e., interconnectivity of medical devices, software and machine learning diagnosis with the help of Big Data). In doing so they demand highly skilled resources in each field of it. EUMEDIQ is often asked by startups for support in regulatory consulting during design & development stages. The experience

One of the big changes in EU MDR 2017/745 in contrast to the MDD are the clear requirements on the handling of substances which are carcinogenic, mutagenic or toxic to reproduction (‘CMR’). Fortunately, manufacturers are not meant to define by themselves which substances are considered CMR. REGULATION (EC) No 1272/2008, Annex VI, part 3 provides

Since the GDPR ((EU) 2016/679) came into force in May 2018, the way we need to go concerning personal data has changed and many obligations were placed on controllers and processors of personal data. But what about the manufacturers of medical devices? Some might say they do not need to do anything – EUMEDIQ would