Medical device
regulatory consulting

Medical Device Regulatory Consulting EU

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.