EU IVDR 2017/746 Gap Assessment and CE Transition Support for Medical Device Manufacturers

ANSWERED ON THIS PAGE:

  • When does the change from IVDD to IVDR 2017/746 go into effect?
  • What are the key differences between current EU requirements and the In Vitro Diagnostics Regulation (IVDR)?
  • How should my company begin to transition to EU IVDR compliance?

Europe’s In Vitro Diagnostics Regulation 2017/746 (IVDR) went into force at the same time as the Medical Devices Regulation 2017/745 (MDR). But while MDR is set to take effect in May 2021, the IVDR will not replace the current In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD) until May 2022. This might lead to the impression that IVD manufacturers have plenty of time to get ready for the transition. In fact, right now is the best time to get started planning your company’s strategy. With the transition to the MDR occupying Notified Bodies, and the significant number of IVD manufacturers transitioning from CE marking self-certification to Notified Body involvement, there will likely be backlogs and evolving enforcement mechanisms that could cause delays.

Emergo by UL is ready to help your team transition from IVDD to IVDR. Our seasoned regulatory consultants can identify the best transition strategy for you, taking into account your product range, certification cycle, markets served, and Notified Body. We have been in the trenches with the MDR transition and will bring much of this real-world experience to informing your European IVD commercialization strategy.

The most significant changes in IVDR 2017/746

In comparison to the IVDD, IVDR 2017/746 is based on a life-cycle approach to ongoing CE Marking compliance rather than being concentrated on the pre-approval stage. Procedures for conformity assessment will become more complicated for most manufacturers as they transition away from self-certification, with Technical Documentation undergoing Notified Body assessment in the majority of cases.

You will need to prepare for intense scrutiny of your analytical and clinical performance data and Performance Evaluation Report (PER), which will require continuing updates. You will also face more stringent post-market surveillance requirements, need to conduct Post-Market Performance Follow-up (PMPF), and be expected to produce Period Safety Update Reports (PSUR) for Class C and D devices. Our white paper introducing the IVDR has more details about the differences from IVDD.

CREATE YOUR IVDR TECH FILE FASTER

Identifying compliance gaps for EU IVDR 2017/746

Even this far out, 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.

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