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 legislationin 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 2017, 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 2017/746 on April 5th, 2017, the In-Vitro Diagnostics Medical Device Directive 98/79/EC was the only applicable legal framework since October 7th, 1998.
There are many substantial changes to consider when planning a successful transition from IVDD to IVDR in due time. For instance, a completely new classification system has been introduced, that follows a risk-based approach, similarly to the Medical Devices one.
- IVDR entered into force on 26 May 2017
- IVDR fully applies from 26 May 2022
- CE Certificates issued under the Directive before 26 May 2022 may remain valid for up 27 May 2025
- IVDR introduces a new system of risk-based classification (Class A, B, C,D)
- While 70% of IVDs entering the EU Market under the IVDD were considered "self-declared", under the IVDR 70% of IVDs will need to mandate the intervention of a Notified Body accredited under the IVDR in order to obtain the CE Mark and enter the EU market.
- The IVDR transitional period for “legacy” devices (above up-classified devices that will newly need a Notified Body and devices with a valid IVDD Certificate) is the following:
26 May 2025 for placing on the market of class D devices & devices with a valid IVDD Certificate [can be made available or put into service until 26 May 2026]
26 May 2026 for placing on the market of class C devices [can be made available or put into service until 26 May 2027]
26 May 2027 for placing on the market of class B devices [can be made available or put into service until 26 May 2028]
26 May 2027 for placing on the market of class A devices placed on the market in sterile condition [can be made available or put into service until 26 May 2028]
- Non-legacy devices entering the market from 26 May 2022 must fully comply with the IVDR
- 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
- IVDs Importers/ Distributors
National Registration Services
As the EU is not one single country, Member States may choose to impose an additional registration in order to make the product available on their market. In most cases, this is a one-time requirement, unless a significant change has been made to the product.
Once the EUDAMED is fully functional, the registration requirements for medical devices may change.
However, at the moment the below countries are imposing an additional registration for medical devices and some specific requirements for cosmetic products that are to be placed on their market in which Obelis can assist you:
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!
Stay up to date on all things In-Vitro Diagnostics Regulation in the EU Market. Join our mailing list today!