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Specialists in SaMD, IVDs, and diagnostics
Experienced team with regulatory and quality assurance backgrounds
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Helpful Links for Medical
Device & IVD Compliance

This page brings together the regulatory sources our consultants use every day. Official guidance, notified body directories, and global device databases. We’ve gathered the key regulatory and industry links that MedTech professionals rely on, from the MHRA and European Commission to the FDA and Health Canada. You’ll also find helpful resources on quality management, notified bodies, and international medical device standards.

Useful Links


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

Regulations

Market Medical Device Regulation URL
United Kingdom Medical devices regulation and safety
EU Medical Device Directive 93/42/EEC
Active Implantable Medical Device Directive 90/385/EEC
In-Vitro Diagnostic Directive 98/79/EC
In-Vitro Diagnostic Regulation 2017/746
Medical Device Regulation 2017/745
United States Establishment Registration – 21 CFR Part 807
Medical Device Listing – 21CFR Part 807
Premarket Notification 510(k) – 21 CFR Part 807 Subpart E
Premarket Approval (PMA) – 21 CFR Part 814
Investigational Device Exemption (IDE) – 21CFR Part 812
Quality System Regulation (QS regulation) – 21 CFR Part 820
Labeling – 21 CFR Part 801
Medical Device Reporting – 21 CFR Part 803
Canada Canadian Medical Device Regulation
Australia Therapeutic Goods (Medical Devices) Regulations 2002
Japan PMDA Regulations
Brazil ANVISA Medical Device Regulations
Saudi Arabia SFDA Medical Device Regulation

Standards

Standard Standard URL
ISO 13485 – Medical Devices ISO 13485:2016
ISO 14971 – Risk Management ISO 14971:2019
Harmonised to IVDR (EU) 2017/746 Harmonised to IVD Directive 98/79/EEC
Harmonised to MDR (EU) 2017/745 Harmonised to MD DIrective 93/42/EEC
UK Designated Standards (IVD) UKCA Designated Standards List for IVDs
UK Designated Standards (MD) UKCA Designated Standards List for Medical Devices
UK Designated Standards (AIMD) UKCA Designated Standards List for Active Implantable Medical Devices

Need help interpreting any of these regulations or updates?

Email hello@imedconsultancy.com, and our experts will guide you to the most relevant information for your device.