Intro to In Vitro Diagnostics in the EU Market
Until the publication of the In-Vitro Diagnostic Medical Device Regulation on April 5th, 2017 and the subsequent five year transition period, the In-Vitro Diagnostics Medical Device Directive 98/79/EC was the reigning legal framework for in-vitro diagnostic medical devices in the EU since its publication on October 7th, 1998.
Under the IVDR, there are many substantial changes to consider when planning a successful transition by the deadline. In particular, the classification system has undergone a complete overhaul to introduce risk-based classifications much like medical devices and other global markets.
- IVDR entered into force on 26 May 2017
- IVDR fully applies from 26 May 2022
- CE Certificates issued before 26 May 2022 may remain valid for up to two years (26 May 2024)
- All devices to enter the market from 26 May 2024 must fully comply with the IVDR
- IVD products already on the market under the IVDR may continue to be made available until 26 May 2025
- In-Vitro Diagnostic Medical Device Directive 98/79/EC
- In-Vitro Diagnostic Medical Device Regulation 2017/746/EU
- IVDR Transition Guide
Allow Obelis to support you in completing a technical file review and gap analysis to make the necessary upgrades to the In-Vitro Diagnostic Medical Device Regulation by the May 2022 deadline.
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