MDR-Consulting

EU MDR

MDR-Consulting is the independent practice of Hans-Heiner Junker in Schüttorf, Germany. He advises medical-device economic operators on implementing Regulation (EU) 2017/745, drawing on prior experience in certification and notified-body roles. Support covers technical documentation, clinical-data questions, UDI, EUDAMED, post-market surveillance and PMCF. The practice delivers focused training, workshops, webinars and ad hoc advisory sessions for organizations needing additional MDR expertise or capacity.

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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

Getting Started

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

Updated 9 months ago

Dr. Oliver Eidel