Acorn Regulatory

EU MDR IVDR

Acorn Regulatory is a regulatory affairs consultancy headquartered in Clonmel, Ireland. Its medical device services include CE-marking strategy, device classification, ISO 13485 quality systems, EU Authorised Representative work, outsourced PRRC support, post-market surveillance and vigilance. The firm works with medical device and in vitro diagnostic manufacturers and is registered in Ireland as an economic operator for its representation activities.

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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

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Authorised Representative For Non-EU Manufacturers

Updated about 1 year ago

Sebastian Skorka