Helpful Links

Useful Link URL
MHRA Guidance on registration of certain medical devices which are reusable Class I devices, upclassified Class I devices, and/or reliant on expired/expiring CE certificates
EU MDR Article 120 extension confirmation template
NANDO (Notified Bodies)
MedTech Europe
The British In-Vitro Diagnostics Association (BIVDA)
Medilink UK
The Association of British HealthTech Industries (ABHI)
Medicines and Healthcare products Regulatory Agency (MHRA)
International Medical Device Regulators Forum (IMDRF)
Medical Device Single Audit Program (MDSAP)
Center for Devices and Radiological Health (CDRH)
FDA Medical Device Databases
Health Canada - Medical Devices Active Licence Listing (MDALL)
Australian Register of Therapeutic Goods (ARTG)
NBOG F 2017-4 IVR Codes for IVDR 2017/746
NBOG F 2017-3 MDA Codes for MDR 2017/745
MDCG Guidance Documents

Please get in touch if you wish to discuss any of the contents of this page with one of our consultants at hello@imedconsultancy.com.