ANSWERED ON THIS PAGE:
- What is the regulatory process for IVDs in Europe?
- What is the European classification scheme for IVDs?
- How will IVD requirements change under the new In-Vitro Diagnostic Regulation (IVDR)?
CE marking is required for all in vitro diagnostic (IVD) devices sold in Europe. CE marking indicates that an IVD device complies with the European In-Vitro Diagnostic Devices Directive (IVDD 98/79/EC) and that the device may be legally commercialized in the EU. Europe's new In Vitro Diagnostic Regulation (IVDR 2017/746) went into effect in May 2022, ushering in substantial changes to EU regulatory requirements for IVDs.
IVD device classification in Europe
There are four classes of IVDs:
- General IVD (Self-Certified)
- Self-Testing IVD
- List B IVD (Annex II)
- List A IVD (Annex II)
Under the IVDR, there will be four risk-based classes — A, B, C, and D. Most self-testing IVDs will fall under Class C, and many IVDs currently classified as self-certified will be classified as higher risk.
The CE process for IVDs is similar to that for medical devices, but there are some key differences. Download our chart explaining the CE Marking process for IVDs. Please note that significant changes to this process will occur once Europe enforces the new IVDR.
Experienced technical file preparation and CE Marking support for IVD companies
IVD manufacturers must compile a Technical Documentation File showing compliance to the IVDR. Your IVD Technical Documentation File must include information about your design, intended use, risk assessment and route to conformity with the IVDR requirements. Based on classification of the IVD, some IVDs' technical documentation will need a Notified Body to review them and issue a CE marking certificate. Once completed, it must be made available to European Competent Authorities upon request.
As part of our European IVD registration services, Emergo can assist with the following:
- Identify the proper classification for your IVD, if unclear.
- Determine specific testing requirements for your device, along with applicable standards and MEDDEV documents.
- Review existing documentation to determine compliance with Essential Requirements of 98/79/EC.
- Review your existing technical file or design dossier to identify and address any gaps in your documentation.
- Perform an assessment of your clinical evidence and prepare your Clinical Evidence Report.
- Assist with Notified Body selection.
- Act as your official Authorized Representative in Europe.
- Conduct a risk assessment in accordance with EN ISO 14971:2012.
- Assist with developing vigilance and post-market surveillance procedures.
- Help you comply with ISO 13485:2016 and prepare for certification audits as needed.
Emergo represents hundreds of IVD companies worldwide. We have successfully registered thousands of IVDs in Europe and many other markets, such as Canada and Australia.
Common questions regarding EU CE Marking for in-vitro diagnostic (IVD) medical devices
Do we need an Authorized Representative (EC REP) if we are marketing a self-certified IVD?
Yes. You must select an EC REP if you do not have a place of business in Europe, regardless of the category or classification of your IVD. Read more about Emergo Authorized Representation services.
Are Notified Body audits required for all types of IVDs?
Unless you are marketing a self-certified IVD device, you will need the intervention of a Notified Body and a Notified Body CE Certificate. In fact, most IVD manufacturers will need to engage Notified Bodies as part of the conformity assessment procedures under Europe's new In Vitro Diagnostic Regulation (IVDR 2017/746).
How will the IVDR affect current CE marking certification for our product?
The IVDR went into force in May 2022. CE certificates issued under the IVDD will remain valid until May 2025. Further, general IVDs (under the IVDD) that are placed on the market before the Date of Application (DoA) and are up-classified under the IVDR have additional time to comply with the IVDR. General IVDs (under the IVDD) that are Class A nonsterile under the IVDR will have to comply with the IVDR by the DoA. It is also important to note that article 110(3) of the IVDR applies to all devices as of May 26, 2022.