MDProject

EU MDR IVDR FDA Clinical Evaluation

MDProject is an independent medical device quality and regulatory consultancy in Alphen aan den Rijn, the Netherlands. It supports EU and US approvals for devices including implants, diagnostic equipment, software and IVDs. Services include MDR, IVDR and US quality-system compliance, technical dossiers, clinical and biological evaluation, risk management, software validation, ISO 13485 implementation, auditing and training.

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Getting Started

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

Updated 9 months ago

Dr. Oliver Eidel

Is additional registration required in France for MDR Class I device already registered in Germany?

Anonymous · 1 comment

8 months ago

Our company is a non-EU manufacturer with an assigned EU Authorized Representative. Our MDR Class I medical device is already registered with the competent authority in Germany. Do we need to register

Accepted 1 answer

For MDR Class I devices, registration requirements may vary between EU member states, even if you already have registration in one country. Based on s

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