上海郜盟参加欧盟体外诊断医疗器械法规(IVDR)研讨会，并就体外诊断医疗器械CE认证成立专门项目组。

 

In Vitro Diagnostic Regulation (IVDR) :欧盟体外诊断医疗器械法规
Regulation EU 2017/746 of the European Parliament and of the Council of April 5 2017 on in vitro diagnostic medical devices.

 

研讨会主题：

1. IVDR法规监管范围如何扩大？

2. IVD器械新的分类规则和合规审核要求有哪些？

3. 如何满足上市前合规审核加严的要求？

4. 性能评估包括哪些？

5. 标识和可追溯措施有哪些？

6. 如何加强产品上市后监督和警戒活动？

 

体外诊断医疗器械CE认证制造商职责：

Manufacturers：

• Design and manufacture in accordance with the requirements of the IVDR including:
  • Conformity to all relevant General Safety and Performance Requirements (Annex I)
  • Risk management
  • Performance evaluation (see Article 56 (Chapter VI, Clinical evidence) and Annex XIII)
• Draw up and keep up to date technical documentation (see Annex II and III):
  • Retain technical documentation for at least 10 years after the last device has been placed on the market
  • Technical File maintained up to date – can be reviewed by NB and/or CA
• Provide an EU Declaration of Conformity (DoC) (see Article 17)
• Must comply with Unique Device Identification (UDI) system requirements (Article 24)
• Registration requirements (Manufacturer - Article 28)
• Written mandate for Authorized Representative, if required
• Appoint person with responsibility for regulatory compliance (Article 15)
• Registration requirements (Devices - Article 26)
• Implement a QMS to ensure procedures are in place to maintain compliance, which will be kept up to date and continually improved
  • The QMS aspects are listed under Article 10.8; including the new provisions laid down by the IVDR for clinical evidence, post-market surveillance plan, UDI
• Post Market Surveillance (PMS) System will be proportionate to risk (Article 78)
• Labelling will be provided (as per the General Safety and Performance Requirements (GSPRs), Annex I) in the official language/s of the member state concerned of the user
  • Labels should be clear, easily legible, clearly comprehensible and indelible
  • Symbols may be used
• Corrective action for nonconforming devices placed on the market or put into service
• System for recording and reporting incidents and field safety corrective actions vigilance (Articles 82 and 83)