AseBio expresses concern about Spain's ability to certify medical devices

  • The current scenario shows a worrying bottleneck with a detriment to innovative biotech products, indefinitely delaying their access to the market.
  • Currently in Europe only 12 conformity assessment bodies have managed to become notified bodies with the regulation (EU) 2017/746.
  • In the case of Spain, we have the National Certification Center for Medical Devices as a notified body for medical devices under Regulation (EU) 2017/745, but it has not been designated for Regulation (EU) 2017/746 for IVD products.


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Industrial biotechnology

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

In January 2024, a new proposal to amend 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 estimated to be the last to be approved and still needs to be given the green light by the European Parliament and Council.

According to the proposed amendment, the transition period is only extended for manufacturers who have an ongoing contract with the notified bodies. This is intended to give notified bodies the additional time needed to complete the processing of conformity assessments before the end of the transitional period.

Currently in Europe only 12 conformity assessment bodies have achieved notified body status for regulation (EU) 2017/746 and 44 for regulation (EU) 2017/745. With the new regulation, all in vitro diagnostic products in the European Union, both new and those approved under the previous directive, must pass through one of these notified bodies to receive the go-ahead for release to the market. This has led to an increase in certification needs, far beyond the capacities of the current notified bodies, which are too few in number to meet the existing demand.  

In the case of Spain, we have the National Certification Center for Medical Devices as a notified body for medical devices in accordance with Regulation (EU) 2017/745. In July 2021, it started the application to be designated as a notified body by Regulation (EU) 2017/746 for IVD products, but it has not yet been successful.

The scenario we observe reflects a worrisome bottleneck that is detrimental to innovative biotechnology products. The current framework indefinitely delays their access to the market to the detriment of European citizens and small companies, whose future depends exclusively on the commercialization of a single product. As can be seen in the report published this March by the European Commission, whether for medical devices or IVD products, most of the clients of the notified bodies are small companies, which implies a higher risk for them. 

While the rate of certification has increased faster than the growth in applications, the net difference between applications and certifications granted continues to widen. As a result, the backlog of applications continues to accumulate and the bottleneck continues to be maintained.

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Data from the European Commission's survey of notified bodies reveal that only three of the 12 notified bodies have reported that more than 50% of their applications have managed to complete all the information required to be certified. In this regard, the main reason for rejection of applications by notified bodies does not refer to incomplete applications for certification, but to other reasons. 

This survey also shows that the time to achieve In Vitro Diagnostics certification ranges between 13 and 18 months for 60% of the notified bodies, between 19 and 24 months for 30% and more than 24 months for 10%. In addition, several AseBio member companies have shared their concern about the lack of response from some notified bodies to requests for offers to work with them, or delays in doing so due to the backlog of work. 

The industry considers the approval by the Congress of Deputies of the Royal Decree on In Vitro Diagnostic Products to be a national priority, as well as to accelerate the designation of the National Center for the Certification of Medical Devices as a notified body. Once the center has the designation, prioritization channels are needed for innovative products developed by Spanish companies and/or those aimed at orphan diseases. 

The designation in our country of the CNCPS as a notified body for IVDR would contribute to reduce the referred bottleneck, but it will not be the solution to the current problem, so the designation of new notified bodies in our country should be assessed, as well as the possibility of providing the National Center for the Certification of Medical Devices with more public resources to meet the current certification needs.

In addition, due to the difficulties that a significant number of companies are having in completing their applications, it would be advisable to support and train companies on the necessary documentation to be submitted to the notified bodies for the evaluation of their products, in order to avoid negative responses that delay the progress of innovations to the detriment of citizens. 

Contact information

Ángel Luis Jiménez
Communication Director
662 172 126 

Carlos Sanz
Communication and Digital Contents Technician 

More information

AseBio brings together 300 entities and represents the entire Spanish biotechnology sector. Its mission is to lead the transformation of the country by positioning science, innovation, and especially biotechnology as drivers of economic growth and social well-being. Among its members are companies, associations, foundations, universities, technology centers, and research institutions that directly or indirectly engage in biotechnology-related activities in Spain.