Our coverage of medical devices in C2P provides up-to-date global coverage of laws and regulations, proposed, enacted & amended, as well as relevant standards, guidance documents, factsheets and more, impacting the placing on the market of medical devices.
Sources in C2P
Regulatory Content Overview
The medical device landscape is undergoing significant changes, and staying on top of these evolving regulations is of critical importance. Our coverage of medical devices ensures that the medical devices you bring to market are safe and compliant.
Our medical device topic covers:
- Definition of medical devices
- Classification of medical devices
- Safety & efficacy/performance requirements
- Conformity assessment procedures
- Technical documentation
- Labeling and packaging
- Testing (clinical trial and evaluation)
- Provision of product information
- Record keeping
- Mandatory Unique Device Identification (UDI) mechanisms
- Quality Management Systems
- Requirements for qualified persons
- Post-market surveillance and consumer protection
Our regulatory content in C2P is historically comprehensive with a robust QA process to ensure quality, consistency and accuracy. Below is a high level summary of our coverage for this topic:
- EU Medical Devices, Regulation (EU) 2017/745
- EU In Vitro Diagnostic Medical Devices, Regulation (EU) 2017/746
- EU Regulation (EU) 2020/561 on deferral of dates of application of MDR
- INMETRO Ordinance No. 384/2020 on approving conformity assessment requirements for health surveillance equipment
- Chinese Announcement No. 147 of 2020, Classification Catalogue of Medical Device
- Chinese Regulation No. 276 of 2000 for the Supervision and Administration of Medical Devices
- USA: CFR Title 21 Parts 801, 803 et al.
- FDA Guidance for Industry and FDA Staff, Medical Device Reporting for Manufacturers 2016
- Japanese law on securing quality, efficacy and safety of products including pharmaceuticals and medical devices 8/1960 Law (PMD Act) No. 145 (as amended No.50 of 2015)
- Japanese Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and in Vitro Diagnostic Reagents MHLW Ministerial Ordinance No. 169 (2004)
- EU: Publication of Harmonised Standards for Medical Devices, Commission Communication, 2017/C 389/03, Harmonised Standards for Directive 93/42/EEC
- UK: BS EN IEC 60601-2-20:2020 Medical electrical equipment, 2020
Learn more about our Regulatory Coverage
Speak to one of our team today for more information on our regulatory content.