Certification Experts

AR for medical devices: a comprehensive guide

What is an authorised representative and do you need one to sell your medical device within the European Union? Legislative changes like Brexit and the new MDR 2017/745 complicate this question, but look no further. We’ve outlined the most important information to keep in mind during the CE marking process of your medical device.

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Brexit is official. What’s next?

Today marks the official date that the United Kingdom leaves the EU. A transition period will be effective immediately, during which the EU and UK will undergo negotiations about future legislation and trade agreements. This period is forecasted to last until the end of 2020. How will trade and certification processes be affected? Read on.

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Is your file ready for the new Medical Device Regulation?

On 26 May 2020 the transition period will end and the Medical Device Regulation (MDR) 2017/745 enters into force and the current Medical Device Directive (MDD) 93/42/EC will be repealed. This means that from 26 May 2020 the technical documentation of your medical devices must be in compliance with the MDR requirements.

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The CE Marking Process Explained

The CE certification process can be overwhelming. That’s why Certification Experts provides flexible tailor-made solutions to simplify the process. For over 25 years, we have been sharing our knowledge to achieve client goals every step of the way. If you are getting started with the CE marking process, here’s our comprehensive list of fundamentals to consider. 

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Which countries and areas accept the CE Mark?

While mandatory, CE Marking remains a complicated process that varies slightly in every case. Aside from the general list of EU directives, each member state has its own set of legislations to follow. In the beginning, the European Union (EU) trade market appears like a maze. For those feeling lost about navigating the EU consumer market, here are some facts about CE compliant countries that will help bring clarity.

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