Accumed

EU MDR IVDR

Accumed is a Swiss medical device consultancy based in Morbio Inferiore. It advises start-ups and small and medium-sized manufacturers on regulatory strategy and market access in Switzerland, the European Union and the United Kingdom. Its regulatory work includes MDR and IVDR representation, documentation review, product classification, vigilance and authority liaison, alongside separate commercial market-development services.

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Is ISO 13485 certification required before CE marking for software medical devices in the EU and Switzerland?

Anonymous · 1 comment

6 months ago

We want to certify our software as a medical device in the EU and Switzerland. I have two questions: • Is it necessary to first obtain ISO 13485 certification before applying for CE marking? What are

Accepted 4 answers

For your first question: MDR requires manufacturers to establish a QMS (Quality Management System), as stated in Article 10 MDR. For class IIa devices

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