European CE Marking for In Vitro Diagnostic (IVD) devices
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 (98/79/EC) and the device may be legally commercialized in the EU. Europe's new In Vitro Diagnostic Regulation (IVDR 2017/746) will come into force in 2022, ushering in substantial changes to the 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 of 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 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 IVD’s 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
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 will come into force in 2022. CE Marking certificates issued before final implementation of the IVDR will remain valid for a maximum of two years following final implementation of the new regulations. If your IVD is self-certified under the IVDD, and Class A sterile, B, C or D according to the IVDR, you must possess a Notified body issued CE marking certificate on 26 May 2022 in order to continue market the IVD in the EU.