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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?
  • Are technical files required for CE Marking of IVDs?

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 that the device may be legally commercialized in the EU. There are four classes of IVDs:

  • General IVD (Self Certified)
  • Self-Testing IVD
  • List B IVD (Annex II)
  • List A IVD (Annex II)

While the CE process for IVDs is similar to that of medical devices, there are some key differences. Download our chart explaining CE Marking process for IVDs. Please note that significant changes to this process will occur once Europe enforces the new In Vitro Diagnostic Directive (IVDR). Download a copy.

Experienced technical file preparation 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. 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
  • Preparation of Clinical Evaluation Report based on provided clinical data
  • 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 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 worldwide such as Canada and Australia.

Please contact us to learn more about our CE consulting services for European IVD CE Marking.

Ask us for detailed information about Europe IVD registration services.

Learn about the process, costs and timelines.

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Common Questions

Do we need an Authorized Representative if we are marketing a self-certified IVD?
Yes. You must select an AR 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.

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).

How will IVDs be classified under the new IVDR?
Under the IVDR, there will be four risk-based classes — A, B, C, and D. Most "self-testing" IVDs will fall under Class C; many IVDs currently classified as self-certified will be classified as higher risk.

How will the IVDR affect current CE Marking certification for our product?
The IVDR will come into force in late 2021 or early 2022. CE Mark certificates issued before final implementation of the IVDR will remain valid for a maximum of two years following final implementation of the new regulations.