Medical device
regulatory consulting
EU MDR & Medical Device Regulatory Consulting
CE marking under EU MDR 2017/745 is a multi-step process (classification, technical documentation, clinical evaluation and Notified Body engagement), and delays at any point push back your entire timeline. AML Global manages the full CE marking pathway for Class I–III devices, including EU Authorised Representative services for non-EU manufacturers and UK Responsible Person registration for MHRA compliance. Post-certification, we support post-market surveillance, vigilance reporting, and variation management.
Frequently asked questions
Do I need to register my medical device with AEMPS to sell it in Spain?
Yes. Economic operators marketing medical devices or IVDs in Spain must submit a commercialisation notification in RECOPS, the AEMPS registry. Devices notified in EUDAMED before 28 May 2026 have until 28 November 2026; for the rest, the notification must be made before the device is placed on the Spanish market. See our step-by-step RECOPS guide.
Is being registered in EUDAMED enough to sell in Spain?
No. RECOPS pulls device data from EUDAMED, but it is a separate national registry and the notification is still mandatory. Read what RECOPS is and who must register.
Can you act as our EU Authorised Representative?
Yes. We provide EU Authorised Representative services for manufacturers based outside the EU, and UK Responsible Person registration for MHRA compliance.
Which device classes do you support under EU MDR?
We support Class I, IIa, IIb and III devices under Regulation (EU) 2017/745, from classification and technical documentation to clinical evaluation, Notified Body engagement and post-market surveillance.