Steps to CE Marking an IVD Medical Device

One of the most frequent questions we are asked is: how do you CE mark an IVD device?  We will look at the steps that you need to take to obtain when CE marking an IVD device. As the new IVDR comes on stream, we will continue to revisit and revise this article to ensure that it is up to date.

What Is The Definition of an IVD Device?

Does the product meet the definition of an in vitro diagnostic medical device? The first step is to determine if your product meets the definition of a medical device under the EU In Vitro Diagnostic Medical Device Directive (IVDD) 98/79/EC definition:  ‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

• concerning a physiological or pathological state, or
• concerning a congenital abnormality, or
• to determine the safety and compatibility with potential recipients, or
• to monitor therapeutic measures.

It should be noted that: Specimen receptacles e.g. blood collection tubes, are IVD’s. Products for general laboratory use are not IVD’s.

What Is the Intended Purpose of the IVD Device?

You need to define the intended use of the product. Ask yourself – what condition is the product intended to diagnose or monitor? Will the product be used for blood or tissue typing? Who is the intended user (lay person / professional)?

Classification of the IVD

Certain medical conditions and blood and tissue typing are high risk and are listed in Annex II of the IVDD. Annex II, List A includes reagents, calibrators and controls for blood grouping and detection of HIV and hepatitis; Annex II List B includes reagents, calibrators and controls for some infectious and hereditary disease markers, tumour markers and tissue typing. The following table lists the 4 classification categories:

Compliance with the Essential Requirements, Annex I of the IVDD

All classes of IVD’s must comply with the applicable Essential Requirements listed in Annex I of the IVDD. The Essential Requirements include requirements for safety, performance, design and manufacture, as well as labelling and instructions for use requirements.

Technical Documentation

A Technical File must be compiled that describes the design and manufacture of the product, and the solutions the manufacturer has taken to demonstrate conformity with the Essential Requirements of the IVDD. The manufacturer must have the technical documentation available for inspection.

Conformity Assessment Procedure

Several procedures for demonstrating conformity with the directive are outlined in the Annexes of the IVDD. Notified Body involvement is required for CE certification of products other than general class IVD’s. Depending on the conformity assessment procedure and classification of the product, this may include review/approval of the technical file contents and audit of the product design and manufacture. The regulatory requirements for conformity assessment are commensurate with the degree of risk associated with the device, for example, Annex II List A devices must comply with Common Technical Specifications and are batch tested by the Notified Body prior to batch release.

Post Market Surveillance for IVD’s

A system for post-market surveillance must be implemented to ensure that incidents are reported to the national competent authority. A system for review of information gained in the post market phase is required.

Declaration of Conformity and Affixing the CE Mark to the IVD

Once all other steps have been completed, the manufacturer signs a declaration of conformity to the IVDD. The product has the CE Mark applied to the labelling. The product must be registered with the Competent Authority in the country where the manufacturer or EU Authorised Representative is located. Our devices team has a wealth of experience in obtaining CE marking for IVD’s and medical devices. They can assist your company in securing a CE mark.  Contact us today by calling us on 00353 52 61 76706 or completing the form below. [ninja_form id=1]

Further Reading: Steps To Ce Marking A Medical Device

We have also written an extensive article on the issues faced by companies wishing to CE mark a medical device.  You can read the article, in full, here.