Kahlity

EU MDR

Kahlity is a Basel-based consultancy working with medical device, pharmaceutical and drug-device combination companies. Its team provides quality and regulatory advisory, audit readiness, training and operational project support. Medical-device services include regulatory-pathway planning, European and Swiss authorized representation, importer support and training on EU MDR requirements. The firm works across device areas including implants, software, in vitro diagnostics, hearing aids and surgical instruments.

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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

Getting Started

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

Updated 9 months ago

Dr. Oliver Eidel

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