Track applicable regulations and standards ensuring comprehensive compliance coverage across all target markets.
Regulation | Coverage (Full / Partial / None) | Description | Last Review |
---|---|---|---|
EU Medical Device Regulations 2017/745 | Full | Regulations required for CE marking of medical devices in the EU. | 2024-03-15 |
(GDPR) General Data Protection Regulation | Full | Regulates the protection of natural persons with regard to the processing of personal data. | 2024-03-15 |
(MPDG) German Medical Devices Law | Full | Law providing additional medical device requirements to medical products listed in Germany. | 2024-03-15 |
FDA 21 CFR Part 820 | Full | Quality System Regulation for medical devices marketed in the United States. | 2024-03-15 |
FDA 21 CFR Part 814 | Partial | Premarket approval requirements for Class III devices (applicable if pursuing PMA pathway). | 2024-03-15 |
FDA 21 CFR Part 807 | Partial | Establishment registration and device listing requirements for US market. | 2024-03-15 |
ISO 13485:2016 + AC:2018 + A11:2021 | Full | Quality management systems for medical devices. | 2024-03-15 |
ISO 14971:2019 | Full | Application of risk management to medical devices. | 2024-03-15 |
IEC 62304:2006 | Full | Medical device software lifecycle processes. | 2024-03-15 |
ISO 62366-1:2015 + A1:2021 | Full | Medical devices - Application of usability engineering to medical devices. | 2024-03-15 |
ISO 14155:2020 | Partial | Clinical investigation of medical devices for human subjects (if clinical studies required). | 2024-03-15 |
ISO 15223-1:2016 | Full | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied. | 2024-03-15 |
ISO/TR 24971:2020 | Full | Medical devices - Guidance on the application of ISO 14971. | 2024-03-15 |
ISO 20417:2021 | Full | Medical devices - Information to be provided by the manufacturer. | 2024-03-15 |
Regulation | Coverage (Full / Partial / None) | Description | Last Review |
---|---|---|---|
MDCG 2020-1 | Full | Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software | 2024-03-15 |
MDCG 2020-5 | Full | Guidance on Clinical Evaluation – Equivalence | 2024-03-15 |
MDCG 2019-11 | Full | Guidance on Qualification and Classification of Software | 2024-03-15 |
MDCG 2019-16 rev.1 | Full | Guidance on cybersecurity for medical devices | 2024-03-15 |
MDCG 2020-7 | Full | Guidance on PMCF plan template | 2024-03-15 |
MDCG 2020-8 | Full | Guidance on significant changes to the intended purpose | 2024-03-15 |
MDCG 2020-13 | Full | Guidance on clinical evaluation of medical devices | 2024-03-15 |
MDCG 2022-12 | Full | Guidance on harmonized administrative practices and alternative technical solutions until Eudamed is fully functional | 2024-03-15 |
MDCG 2019-7 | Full | Guidance on Article 15 of the MDR and IVDR regarding a “person responsible for regulatory compliance” | 2024-03-15 |
MDCG 2022-21 | Full | Guidance on Periodic Safety Update Reports (PSURs) according to Regulation (EU) 2017/745 | 2024-03-15 |
MDCG 2018-1 rev.4 | Full | Guidance on basic UDI-DI and changes to UDI-DI | 2024-03-15 |
FDA Software as Medical Device Guidance | Full | FDA guidance on software as a medical device (SaMD) regulatory framework | 2024-03-15 |
FDA Cybersecurity Guidance | Full | Content of Premarket Submissions for Management of Cybersecurity in Medical Devices | 2024-03-15 |
FDA Clinical Evaluation Guidance | Partial | Clinical evaluation guidance for specific device types (as applicable) | 2024-03-15 |
FDA 510(k) Guidance | Partial | Guidance for 510(k) submissions (if pursuing 510(k) pathway) | 2024-03-15 |
ISO/IEC 27001:2013 | Partial | Information security management systems (for cybersecurity compliance) | 2024-03-15 |
NIST Cybersecurity Framework | Partial | Framework for improving critical infrastructure cybersecurity | 2024-03-15 |
How often should I update the list of regulatory requirements?
What's the difference between regulations and guidance documents?
How do I determine if a requirement applies fully or partially to my device?
Should I include standards that are referenced in regulations?
How do I stay informed about regulatory changes?
What should I do if I discover a new applicable requirement?