Device Quality

EU MDR FDA

Device Quality is a medical device quality and regulatory practice based in County Kilkenny, Ireland. Clients work directly with principal consultant Mark Kelleher on quality management systems, FDA submissions, CE marking, EU MDR compliance, ISO 13485, risk management and post-market surveillance. The practice also supplies outsourced PRRC and management representative support and fractional senior QA/RA leadership for device manufacturers.

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Are EU MDR obligations triggered if an EU manufacturer sells via a distributor outside the EU?

Anonymous · 1 comment

6 months ago

Does the EU MDR place any obligations on an EU-based manufacturer if a product is sold outside the EU through a distributor? For example, if our company manufactures a device in the EU and sells it in

Accepted 2 answers

The MDR only applies to devices that are placed on the market, made available, or put into service within the EU. So, if you sell your product outside

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

Getting Started

EU MDR: Step-By-Step Guide To Becoming Compliant

Updated 9 months ago

Dr. Oliver Eidel