In order to move freely within the Union territory, all in-vitro diagnostic (IVD) devices must be CE marked. The CE Marking serves as a declaration from the manufacturer that their product complies with the essential requirements of the European In-Vitro Diagnostic Devices Directive (IVDD 98/79/EC).
As it might not always be easy to understand the path to EU compliance, let us guide you through some of the most frequently asked questions we often receive.
Is my device an In Vitro Diagnostic Device? And if so, how do I classify it?
Under the IVDD 98/79/EC, an In-Vitro Diagnostic Medical Device is defined as:
“any medical device which is a reagent, reagent device, 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.”
Products for general laboratory use are not IVDs unless such products, in view of their characteristics, are specifically intended by their manufacturers to be used for in-vitro diagnostic examination.
IVDs are classified into 4 main groups:
- Devices listed in Annex II, List A;
- Devices listed in Annex II, List B;
- Devices for Self-testing not listed in Annex II;
- All other devices (all devices except Annex II and Self testing devices).
Therefore, in order to understand how you should classify your device, you can simply ask yourself the following questions:
- Is my device present in the closed inventory of either List A or B of Annex II IVDD 98/79/EC?
- Is my device intended for self-testing?
If the answer to both questions is no, then your device is classified as “all others”.
What is an European Competent Authority? And do I need to notify my device to one of them before placing it on the market?
The European Competent Authorities are the local regulating bodies in each EU Member State, and they ensure the market surveillance. All IVDs must undergo a pre-market notification to the Competent Authorities before being made available on the market. However, IVD products are not being “approved” by the Competent Authorities prior to their sale in the EU; compliance is verified through in-market controls.
What is a Notified Body? Do I need one?
Notified Bodies are organizations which have been accredited by an EU Member State Competent Authority to assist the manufacturers in carrying out conformity assessment procedures, and to grant conformity certificates to IVDs. Notified Bodies are tasked with ensuring that certain classes of IVDs devices placed on the EU Market are safe and compliant.
There are certain criteria that a Notified Body must meet before the EU Authorities can give them the official accreditation. Selecting a Notified Body for an IVD is an important process. Manufacturers can consult the European Commission´s complete directory of Notified Bodies (available on the NANDO website).
You will need to appoint a Notified Body if your device is classified as Self-Testing or listed in Annex II list A or list B of the IVDD 98/79/EC. If your device belongs to one of these categories, your chosen Notified Body will issue the appropriate certification after an exhaustive assessment to ensure that all relevant requirements have been met. Once you receive the Notified Body certificate, you will be able to place the CE marking on your device, demonstrating that it is compliant with the requirements.
If your device is classified as a General IVD (“All others”) you can self-certify that your product complies with the essential requirements of the European In-Vitro Diagnostic Devices Directive, without the intervention of a Notified Body.
If you need assistance in your Notified Body Selection and Negotiation needs, contact us and we will be glad to help you!
What is a European Authorized Representative, and do I need one?
As per Art.1(g) of the IVDD 98/79/EC, an Authorized Representative is “any person naturally or legally established in the European Union who is explicitly designated by the manufacturer to act on their behalf. This person may be addressed by authorities and bodies within the Union, instead of the manufacturer themselves, with regards to the requirements of this Directive.”
If you are a non-EU manufacturer you must appoint a European Authorized Representative established within the European Union, which will notify your devices towards the EU Competent Authority, where they have the Registered Address.
Obelis is a European Authorized Representative with more than 30 years of experience in the field!
The table below should help you assess the main steps needed for your IVD, based on its classification:
Remember that, as of May 2022, Europe’s new In Vitro Diagnostic Regulation (IVDR 2017/746) will come into force, bringing in significant changes to the regulatory requirements for IVDs!
If you wish to know more about IVDR click here and become a member of the most extensive and up-to-date database on MDR and IVDR laws.
Laura Menozzi
Regulatory Affairs Department
25/05/2020
Still having doubts? Obelis, with many years of experience offering consultation and guidance to manufacturers of medical devices, IVDs and cosmetics will be glad to help you. Contact our experts today!