Identifying compliance gaps for EU IVDR 2017/746
It is important to begin with the correct first steps when creating your strategy for transitioning to the IVDR. You can start by identifying ways in which you are and are not in compliance. Conducting an effective gap analysis will provide you with a to-do list for bringing your procedures and documentation up to speed. We can guide you through this critical process.
Next, you can look at the evidence of compliance with the General Safety and Performance Requirements (GSPR) and data supporting your PER such as scientific validity, analytical and clinical performance data. Under the IVDR, Notified Bodies will have greater engagement with manufacturers through conformity assessment procedures, and meeting the new requirements will be a significant challenge for many companies.
Emergo by UL can perform a comprehensive IVDR gap analysis
We can conduct a systematic, independent gap analysis to identify those areas of your documentation, procedures, and processes that need to be revised/updated for compliance to the In-Vitro Diagnostics Regulation. Our most senior consultants will perform this analysis and provide you with a review of your:
- Current IVDD CE Marking Technical File or Design Dossier or draft IVDR CE Marking Technical Documentation File
- Current device class and product families
- Risk Management File
- Performance Evaluation Plan (PEP)/PER(s)
- Labeling
- Post-market surveillance (process, plan, effectiveness, PMPF, and results)
- Economic Operators Agreements Review, including your European Authorized Representative (EC REP) agreement
- Supply and distribution chain management procedures
- Relations with your current Notified Body
- Specific QMS documentation, including records related to designation and qualification of your Person Responsible for Regulatory Compliance (PRRC), UDI, etc.
We will draw up a thorough report explaining where your company fails to comply with IVDR. This report can be complemented by a quality plan outlining the steps to be addressed as your organization works towards IVDR transition. Emergo can also provide support in addressing a number of these gaps, including QMS updates, Technical Documentation File development/remediation, and compilation of RMF, PEP/PER and PMS/PMPF documentation.
Emergo by UL has served IVD manufacturers in the European market since 1997. We have four offices in Europe and act as the official EC REP for more than 1,000 medical device companies, so we are uniquely qualified to help you make a smooth transition to the new In Vitro Diagnostics Regulation.
Now is the perfect time to start. Contact us today and find out how we can help you with your IVDR transition.