- Many European SMEs in the health sector will not be able to certify their equipment in time and will be immediately banned from marketing their products. As a result, they will face serious survival difficulties as their source of income will disappear.
- The Basque Health Cluster is calling the public’s attention to the fact that, despite the efforts in innovation and investment in the health sector, the result is hindered by the increased regulatory requirements for medical devices, which are not complemented by facilities for compliance with these regulations.
- Recent regulatory changes imposed from Europe are forcing important new requirements on the marketing of health products. Following the appearance of Covid-19, new medical devices (medical devices and in vitro diagnostics) have been created that must first be approved and certified in order to be sold in Europe. However, recent regulatory updates have led to a decrease in the number of accredited bodies certifying these products, creating a major bottleneck for their approval in the EU as a whole. In this scenario, different agents from the world of Health in the Basque Country, who make up the Basque Health Cluster, consider it necessary to create new Notified Bodies (Accredited Certifying Bodies), with the dual aim of speeding up the arrival of new products on the market and being able to adapt existing products to the new requirements of European regulations.
A new European regulation sets important new requirements for new medical devices (both medical devices and in vitro diagnostic tests). New products now have to pass new and more stringent health controls and numerous administrative hurdles before they can be approved, homologation and, of course, placed on the market.
In addition, in order to demonstrate compliance with the European regulations, it is an indispensable requirement that the so-called Certifying Bodies (accredited as a href=”https://ec.europa.eu/health/medical-devices-topics-interest/notified-bodies_en” rel=”noopener” target=”_blank”>’Notified Body’ and responsible for certifying the different medical devices to be launched on the market), guarantee compliance with the new regulations. Similarly, the changes introduced by the new regulations mean that medical devices that did not previously require the intervention of the Notified Body now do.
For this reason, the health sector in Europe is facing a serious problem due to the significant reduction in the number of these Certification Bodies, either because the regulations are much more demanding in terms of the criteria to be met by auditors, or because of the limitations of the European Commission in managing new applications.
To get an idea, in the field of medical devices, before BREXIT there were up to 140 ‘Notified Bodies’ in the EU; currently there are only 26 Certification Bodies, of which only 6 are accredited for the field of In Vitro Diagnostics (IVD), which in turn must deal with an enormous and growing workload with the appearance of new medical devices and medical treatments resulting from the health crisis generated by the COVID-19.
In addition, companies that until now could market their medical devices with a CE marking (a requirement for marketing in the EU and valid in most international markets) may find that their product has changed category with the entry into force of the new regulation and, therefore, the requirements to be accredited are now greater and they must also do so through the corresponding ‘Notified Body’.
We are therefore witnessing a major bottleneck, resulting in huge delays, even longer than six months, in the approval and homologation of new medical devices. Moreover, the new regulation is affecting SMEs in particular, as large multinationals have better access to such ‘Notified Bodies’.
In fact, many SMEs are currently having major problems contracting these certifying bodies, either because they have not yet managed to become accredited as auditors under the new standard, or because those already accredited are literally saturated with an avalanche of new medical devices, or because they have exponentially increased the cost of their certification services, which are now only available to large laboratories and companies.
Experts point out that unless the transitional period for adapting to the new regulations is extended, it is likely that many SMEs in the sector in Europe will not be able to certify their equipment in time, leading to a critical scenario for many SMEs throughout Europe, which could even lead to their closure, as they will not be able to market their products because they will not receive certification of their medical devices in time.
In this scenario, agents and companies in the health sector in the Basque Country, specifically the Basque Health Cluster, are calling public attention to the fact that the effort in innovation and investment in the health sector, with greater regulatory requirements for medical devices, is not being complemented by facilities for compliance with these regulations.
For this reason, they call for the urgent creation of a ‘Notified Body’ in the Basque Country in order to speed up the administrative processes required for their certification so that they can finally reach the market.
An example of this is the approval process for COVID-19 detection tests for professional use as a self-diagnosis test, in which Spain, unlike other European countries, only accepts as valid the corresponding EC Certificate, granted by a Notified Body. This decision has caused manufacturers of this type of COVID-19 tests to find themselves at a very complicated crossroads since these Notified Bodies do not have the capacity to accept new applications for certification for COVID-19 self-testing based on the Directive in force.
“The lack of ‘Notified Bodies’ is a serious problem that needs to be addressed as soon as possible in order to avoid the collapse of many small companies in the sector in Europe in general and in the Basque Country in particular”, explains Mikel Alvarez Yeregi, President of the Basque Health Cluster, a leading association in the biosciences and health sector in the Basque Country, which has more than 90 member companies. In his opinion, “the launch of a new certifying body in the area would be a good opportunity that would be very well received by the health industry“.