EUDAMED Registration

by Nikita Angane | Nov 2, 2020 | FDA, Medical Devices, Quality, Registration, Regulatory

The EUDAMED Actors module is all set to start accepting registrations from member states and economic operators from 1^st December 2020. EUDAMED is a portal that consists of 6 modules and the Actors module serves as the establishment registration portal in the EU.¹

Any organization who performs the following roles must register in the actors module and obtain a Single Registration Number (SRN):¹

Commissions
Competent authority (CA)
Designating Authority (DA)
Notified Bodies (NB)
Manufacturers (MF)
Authorized Representative (AR)
System and Procedure Pack Producer (PR)
Importer (IM)

Distributors do not have to be registered in the EUDAMED.¹

After registration, the economic operators will be approved by a competent authority and will be granted an SRN. The SRN uniquely identifies every economic operator and a new SRN must be obtained for each role of the organization. E.g. an organization which is a manufacturer as well as an importer must obtain two SRNs for each of its operations.¹

For non-EU manufacturers, their authorized representative must verify their registration request before it is submitted to the competent authority for approval. To process the registration, all registrants must submit a signed declaration of information security responsibilities, and non-EU manufacturers must also submit a mandate summary document and must have an active authorized representative.¹ While operators are not required to register immediately, you must register in the actors module before you can access the device module which is set to release in May 2021.¹

Need help with EU MDR? Call us today at +1 249-987-4497 or email us at info@emmainternational.com to know more about how we can help.

¹EU Commission (2020) Actor Roles and Actor Registration Process retrieved on 10/29/2020 from https://ec.europa.eu/health/md_eudamed/actors_registration_en

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.