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) will take full effect in May 2022, ushering in substantial changes to EU regulatory requirements for IVDs. Download our white paper about the IVDR to explore the changes in more detail.
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. Download a copy of the IVDR.
Experienced technical file preparation and CE Marking support for IVD companies
IVD manufacturers must compile a technical file or design dossier showing compliance with IVDD 98/79/EC. Your IVD technical file must include information about your design, intended use, risk assessment, and route to conformity with IVDD requirements. Based on classification of the IVD, some IVDs' technical documentation will need to be reviewed by a Notified Body and a CE marking certificate issued. 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.