Emergo by UL

FDA EU MDR IVDR

Emergo by UL is a global regulatory consultancy for medical devices and IVDs, headquartered in Austin, Texas. It supports FDA submissions, EU MDR and IVDR compliance and market access in many other jurisdictions, including in-country regulatory representation services.

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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

Do distributors need to register in EUDAMED under MDR?

Anonymous · 1 comment

6 months ago

I am seeking clarification regarding the registration requirements for economic operators in EUDAMED under the Medical Device Regulation (MDR). Specifically, do distributors (as defined in MDR Article

Accepted 1 answer

Distributors do not need to register in EUDAMED. Only manufacturers, importers, and authorized representatives are required to register according to A

Are distributors required to register in EUDAMED under MDR?

Anonymous · 1 comment

6 months ago

We are reviewing the requirements for economic operators and their registration in EUDAMED. Specifically, do distributors (as defined in MDR Article 14) have to register in EUDAMED? According to MDR A

Accepted 1 answer

Distributors don't need to register in EUDAMED. Only manufacturers, importers, and authorized representatives are required to register. The system cur