The purpose of this IMDRF guidance is to harmonize the documentation and procedures that are 60 used to assess whether a medical device conforms to the regulations that apply in each jurisdiction. The worldwide adoption of fundamental design and manufacturing requirements for medical devices that, when met, provide assurance the device is safe and performs as intended, offers significant benefits to the manufacturer, user, patient or consumer, and to Regulatory Authorities. Eliminating differences between jurisdictions decreases the cost of gaining regulatory compliance and allows patients earlier access to new technologies and treatments.
News & Trends
Procurar
Recentes
- Commission publishes guidelines on transparency obligations for providers and deployers of certain AI systems
- MDCG Position Paper: UDI assignment between manufacturers and distributors
- EMA Questions & answers on Article 31 non-pharmacovigilance referral procedures
- EXTENSION OF THE MDR TRANSITIONAL PERIOD AND REMOVAL OF THE ‘SELL OFF’ PERIODS
- MHRA Updated guidance for the International Recognition Procedure (IRP)
- MDCG 2021-5 Rev. 1 .Guidance on standardisation for medical devices
- Qualification of novel methodologies (QoNM) for medicinal product development . Procedural Guidance to applicants
- FDA Guidance for Drug Development