Most in vitro diagnostic medical devices require the involvement of a notified body or approved body if you want to sell them in the European Union or United Kingdom. A notified body is a third-party entity that assesses the conformity of your IVD medical devices for the European Union markets. The UK equivalent is called approved body. Notified bodies will issue a certificate that allow you to affix the CE marking on your devices, while approved bodies issue a certificate for the UKCA marking.
Regulatory state of play in Europe
Medical devices and IVD medical devices must bear the CE marking if you want to sell them in the European Union and Switzerland. For some additional years, the United Kingdom will still accept CE-marked devices. However, not later than December 2028, all medical devices and IVD medical devices will have to bear the UKCA marking. Already today, non-UK manufacturers need to appoint a UK Responsible Person and register devices as part of the compliance process. In Switzerland, instead, you can sell CE marked devices if you appoint a Swiss authorized representative and go through the Swiss compliance process.
Conformity assessment with a notified body or approved body
The first information to consider when approaching a notified body is the classification of your IVDs. For class A devices, you can evaluate the conformity of your devices with a self-certification. For devices of class B, C, or D, you have to involve a notified body or approved body, depending on which marking you are aiming for. Majority of devices under EU IVD Regulation fall in the higher 3 risk classes that require the involvement of a notified body.
It Is Important to select a notified body that is competent to assess and certify your devices. You can check the designation scope of the certification body on the European Commission website NANDO for notified bodies and UK government website for approved bodies’ scope. It is also essential to approach them as early as possible to avoid waiting in line!
What to do if you do not have the necessary certificates
As your authorised representative in the European Union and Switzerland, and responsible person in the UK, Obelis helps you find a competent & available notified body or approved body that assess your devices. If you do not have the documentation to apply for a notified body or approved body – such as technical file or clinical evaluation – Obelis guides you through the compilation of these documents, preparing you for the application.