EpisKey gives a Webinar on In Vitro Diagnostic Medical Devices

On 19 May, the Episkey webinar on the regulation of In Vitro Diagnostic medical devices took place. More than a hundred people attended this webinar organised by Farmaforum as part of its Farmaforum webinars programme.

Diagnostic medical devices In vitro tests are currently in line with the European Commission Directive IVD 98/79/EC but on 26 May 2022 the new IVD 98/79/EC will enter into force. Regulation (EU) 2017/746 of the European Parliament and of the Council on diagnostic medical devices in vitro and repealing the directive.

What changes in the regulation of in vitro diagnostic medical devices?

The directive provides a regulation for this type of medical devices, but with the entry into force of the regulation, they will be classified according to the risk to patients and the prevalence of the trial. This means that manufacturers must identify the hazard class of their product and comply with the general safety and performance requirements detailed in Annex I of the regulation.

To demonstrate this compliance, manufacturers must perform a Performance Evaluation, equivalent to the Clinical Evaluation of general medical devices. In addition, they have to prepare a technical dossier with a risk management plan and a post-marketing plan, among other documents.

We know that many medical device manufacturers are familiar with all this documentation, but many manufacturers will be facing this task for the first time. That is why EpisKey Medical consulting wanted to summarise the most important aspects through the 5 steps necessary to comply with the IVDR Regulation.

The webinar can be re-watched on our vimeo channel and on the Farmaforum website. If you want to know more, you can visit our social networks, through which we were broadcasting the event.

If you need more information, EpisKey Medical Consulting offers you our help to certify your medical devices.


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