KD&A

EU MDR FDA

KD&A is an Australian medical-device and IVD regulatory consultancy established by Kea Dent. The firm supports regulatory strategy, technical files, ISO 13485 quality systems, audits and post-market surveillance. Its global-registration work includes EU CE marking under the MDR, FDA 510(k), Australian TGA submissions, Health Canada, UKCA and other market pathways.

Learn more

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

3:06

Free MDR Templates

Dr. Oliver Eidel

103 views · over 2 years ago