European In Vitro Diagnostic Regulation (EU IVDR) is a new Regulatory basis for placing IVDs in the European market. The EU IVDR is set to replace the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC). As a European regulation, it will be effective in all the EU member states and the European Free Trade Association (EFTA) states immediately without any need to be transferred into the law of respective States.
Mandated to be effective from May 26, 2022, the new EU IVDR is considered as a significant change to Regulatory oversight of IVDs. Once fully implemented, the IVDR compliance rules ensure almost all IVDs entering the European market are subject to the Notified Body (NB) review and the CE marking certification. In this scenario, apart from aligning with updated IVDR classification there is an immediate requirement for manufacturers to effectively review key technical documentation for successful IVD registration and CE marking. They must perform:
- Technical file reviews as per IVDR 2017/746 regulation
- Performance Evaluation Report (PER) preparation for all the IVDs
- Post-market Performance Follow-up (PMPF) as per Annex XIII Part B of the IVDR
- Vigilance Reporting as per Article 82 of the IVDR
As a proven Regulatory partner, Freyr assists manufacturers for compliant IVD registration and CE marking. Freyr can support in performing a systematic review of the scientific literature and aid in the planning and preparation of a PER for IVDR compliance. Freyr has dedicated experts to support post-market surveillance (PMS), which is an integral part of the manufacturers’ quality management system along with Post-market Performance Follow-up (PMPF).
- Transition plan for the IVDR compliance
- Technical review and gap analysis of the IVDR GSPR compliance
- Support the compilation of the technical file as per IVDR compliance requirements
- Scientific Validity reports based on literature and/or inhouse data
- Clinical Performance Reports based on literature and/or inhouse data
- Clinical Evidence or Performance Evaluation reports
- Post Market Performance Follow up (PMPF) protocols and Reports
- Post Market Surveillance (PMSR) Protocols and Reports
- Writing/revising other documents such as package insert/IFU, Quick Reference Instructions (QRI), operation/user manual etc.
- Assured IVDR compliance, IVD registration, and CE marking
- Strong Regulatory understanding and expertise in EU IVDR key impact areas
- Strong project management driven delivery model to ensure schedule adherence
- Inhouse NB Experts (review of the report by NB interactive reviewers)
- Focused teams with cross expertise on specific impact areas and device categories
- Cross-functional inputs from medical device experts to comply with requirements
- Full-scope of service across compliance, review, and planning
- Strong expertise in maintaining consistency in deliverables (Time and Quality)