CE Marking: MDR and IVDR – all classifications

Helping Medical Device Startups Break Into the UK, EU, USA & GCC Markets

No challenge is too big!Simplimedica has years of experience with CE marking devices under MDD, IVDD, and more recently, the MDR and IVDR classifications. Your device may be –

Sterile/Non-Sterile
Invasive/ Non Invasive
Active/ Active Implantable
Software
Drug-Device combination
Biologic
Point of care/self test
IVD

We have worked with all device combinations. Please check in with us today to confirm that your product is a Medical Device and what the next steps to conformity are.