Unihelp

EU MDR IVDR

Unihelp is a Greek quality and regulatory consultancy based in Pefki. Its medical device services address EU MDR and IVDR requirements, CE marking, EUDAMED registration and registration in Greece’s GreMDIS system. The company presents these services as practical support for businesses and organisations adapting to European regulatory requirements, alongside its wider management-system and product compliance consulting.

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Recommendations for EU Notified Bodies for CE and MDR applications outside Germany

Anonymous · 1 comment

6 months ago

Our company is developing a medical device software and is seeking recommendations for Notified Bodies in the EU, outside of Germany, where we can apply for CE marking and MDR certification within thi

Accepted 2 answers

A few months ago, Kiwa Dare in The Netherlands still had capacity to accept or at least discuss new customers, and they handle medical device software

Is additional registration required in France for MDR Class I device already registered in Germany?

Anonymous · 1 comment

8 months ago

Our company is a non-EU manufacturer with an assigned EU Authorized Representative. Our MDR Class I medical device is already registered with the competent authority in Germany. Do we need to register

Accepted 1 answer

For MDR Class I devices, registration requirements may vary between EU member states, even if you already have registration in one country. Based on s

Is EUDAMED registration mandatory for economic operators in Germany?

Anonymous · 1 comment

6 months ago

I understand from MDCG 2022-12 and Article 28 that EUDAMED registration is voluntary unless a member state requires otherwise. In Germany, it appears that registration in EUDAMED is mandatory for econ

Accepted 1 answer

You can find the information on the website of the German Competent Authority BfArM, specifically under the section 'Anzeigen von Medizinprodukten': h