The new amendment proposal on European IVDR regulation extends the transition period for notified bodies

In May 2022, Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices (IVDR) came into effect. It established new guidelines and requirements for conformity assessment bodies (CABs) to act in accordance with this standard.

A notified body is an organization designated by a EU Member State (or by other countries under specific agreements) to assess the conformity of certain products before they are placed on the market. These bodies are empowered to carry out tasks related to conformity assessment processes, as established in the applicable legislation when the intervention of a third party is necessary.

On January 23, a new amendment proposal to Regulations (EU) 2017/745 and (EU) 2017/746 was published, extending the transition periods by two and a half years for certain IVDR products. This extension is expected to be the last approved and still requires approval from the European Parliament and Council.

According to the amendment proposal, the transition period is only extended for manufacturers with ongoing contracts with notified bodies. This allows notified bodies time to complete the processing of conformity assessments.

Currently, only 12 conformity assessment bodies have managed to become notified bodies under this regulation in Europe. This means that all in vitro diagnostic products in the European Union must undergo assessment by one of these notified bodies to receive approval for market access.

A clear example is the National Center for Certification of Health Products (CNCps), which initiated the application to be designated as a notified body under Regulation (EU) 2017/746 in July 2021 but has not yet achieved it.

According to the results of a survey conducted by the European Commission, 80% of notified bodies indicate that the applications they receive are less than 50% complete. This survey also highlights that the time to obtain In Vitro Diagnostic certification for the entire quality management system and product ranges from 13 to 18 months for 60% of notified bodies, between 19 and 24 months for 30%, and over 24 months for 10%.

Based on this, the observed picture reflects a concerning bottleneck that translates into a detriment to innovative biotechnological products. The current framework indefinitely delays their access to the market to the detriment of European citizens and small companies, whose future depends solely on the commercialization of a single product.