Intro to In-Vitro Diagnostics in the EU Market
In preparing to export your in-vitro diagnostic products to the EU Market, it is important to determine whether or not your products will fall under the scope of 'in-vitro diagnostics' according to this specific legislation in the EU Market. If they do qualify, you will also need to determine the appropriate classification in order to determine your unique path to compliance.
It is a particularly exciting and stressful time as medical device manufacturers worldwide transition from the framework of the In-Vitro Diagnostics Directive 98/79/EC to the In-Vitro Diagnostics Regulation 2017/746/EC. As the Directive has been in place since June 14th, 1998 and was amended in , this will undoubtedly be a great undertaking for medical device manufacturers, Authorized Representatives & Notified Bodies in completing this transition.
EU In-Vitro Diagnostics Legislation
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.
- Non-EU must appoint an Authorized Representative which is established within the community
- 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
- IVDR introduces a new system of risk-based classification which is in line with other international legislation
- While 70% of IVDs entering the EU Market under the IVDD were considered "self-declared", under the IVDR 70% of IVDs will now mandate the intervention of a Notified Body accredited under the IVDR in order to obtain the CE Mark and enter the EU market
- Entering the EU Market with IVDs (Directive)
- Entering the EU Market with IVDs (Regulation)
- In-Vitro Diagnostics Legislation (Directive)
- In-Vitro Diagnostics Legislation (Regulation)
- 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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