EU: MDCG 2024-1 - DEVICE SPECIFIC VIGILANCE GUIDANCE (DSVG) TEMPLATE – MARCH/APRIL 2024
- 2024-04-08 08:12:16
This guidance aims to harmonize vigilance reporting and provide guidance for manufacturers of Specific Devices.
了解更多This guidance aims to harmonize vigilance reporting and provide guidance for manufacturers of Specific Devices.
了解更多This guidance clarifies the exemptions from the requirement to perform clinical investigations, and associated conditions related to the demonstration of equivalence, for implantable and class III medical devices.
了解更多This guidance explains the qualification and classification of products without an intended medical purpose listed in Annex XVI of the MDR.
了解更多This guidance provides demonstration of equivalence for products without an intended medical purpose listed in Annex XVI of the MDR.
了解更多A regulation governing the assignment of Unique Device Identifiers (UDI) for contact lenses has been published.
了解更多This guidance provides clarifications on which specific regulatory considerations apply when the hardware or hardware component are classified as a medical device or an accessory to a medical device.
了解更多This Q&A document answers questions on transitional provisions for products without an intended medical purpose covered by Annex XVI of the MDR.
了解更多The European Commission has published a flowchart helping relevant actors to determine the eligibility, conditions, and deadlines for the placing on the market of certain devices referred to in Article 120 MDR as amended by Regulation 2023/607.
了解更多A survey on certifications and applications of MDR-IVDR was conducted in April 2023. The result of the survey is published.
了解更多Due to Regulation (EU) 2023/607, the transition period is extended. Some timelines of the related factsheet or guidance are modified accordingly.
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