MDS Denmark

EU MDR FDA Clinical Evaluation

MDS Denmark is a Copenhagen consultancy established to serve medical device manufacturers, distributors and importers. It provides regulatory strategy, quality-system support, technical files for EU CE marking and clinical and biological evaluation reports under the EU MDR. Additional services include FDA approval support, PRRC and authorized-representative work, audits, device testing coordination, clinical research services, due diligence and commercialization advice across the medical-device lifecycle.

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Dr. Oliver Eidel

103 views · over 2 years ago

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

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