The importance of certification
The certification of medical devices and in vitro diagnostic medical devices is a crucial factor in ensuring patient safety and regulatory compliance in the healthcare sector. As a member of the European Union (EU), Lithuania follows EU regulations and directives but does not have its own Notified Body to certify these devices. Therefore, this function is currently carried out by institutions in other EU Member States.
Notified Bodies play a highly important role by conducting comprehensive assessments to ensure that all medical devices comply with strict safety standards before entering the Lithuanian and EU markets.
The need for a Notified Body: challenges and opportunities
With the rapid advancement of science and technology, the number of medical devices on the market continues to grow, increasing the demand for certification. Efforts to strengthen the capacity of Notified Bodies, promote cooperation, and streamline processes are essential for effectively addressing these challenges.
Lithuania’s dependence on Notified Bodies from other EU countries creates challenges such as complex communication and coordination, as well as long waiting times due to the high workload of these institutions. However, these challenges also present opportunities. By establishing its own Notified Body, Lithuania could increase certification capacity within the EU and accelerate product certification for market participants, especially small and medium-sized enterprises (SMEs) and start-ups. By developing expert infrastructure, Lithuania could become a trusted medical device certification centre in the EU.
Strengthening the capacity of Notified Bodies
As challenges related to medical device certification and the workload of Notified Bodies are being experienced not only in Lithuania but throughout Europe, the European Commission is preparing measures to address these issues.
According to Diana Vertelkienė, Head of the iVita Health Technology Cluster:
“For the second year, our cluster together with EU partners has been implementing the NoBoCap (Notified Body Increased Capacity) project, aimed at increasing the capacity of Notified Bodies by improving and developing the qualifications of their potential workforce.”
The project provides training and knowledge-sharing activities that help attract newly trained and qualified specialists to Notified Bodies and partially solve the shortage of skilled professionals in the sector.
Another important part of the project is the NoBoCap Community, which brings together organizations operating in the medical technology and health technology fields. Members are united by common challenges related to implementing new medical device and in vitro diagnostic medical device regulations, as well as introducing, using, and regulating innovative technologies such as artificial intelligence in medical devices. Community partners contribute their expertise, experience, and consultancy services to help innovators properly implement ISO 13485 quality management requirements and complete certification processes more efficiently.
In Lithuania, the health technology ecosystem participants that have already joined the NoBoCap community include Smart Health DIH, Tech-Park Kaunas, Biomapas, 2AM Health, and Sertika, which is seeking to become a Notified Body. According to D. Vertelkienė, membership in the community will be especially beneficial for Sertika, helping the company gain access to support, regulatory knowledge, and opportunities to attract new employees and experts.
Sertika’s efforts to become a Notified Body
A significant change may soon take place in Lithuania’s certification sector, as Sertika is making major efforts to become a Notified Body capable of auditing medical devices and later in vitro diagnostic medical devices. This is an important step in strengthening Lithuania’s medical device market and its position within the European healthcare sector.
To obtain Notified Body status, Sertika is preparing internal procedures, searching for specialists in biocompatibility, software, clinical investigations, and sterility assessment, and conducting staff training to prepare for the evaluation process. The assessment of the application to become a Notified Body is expected to take approximately one year.
Responding to questions about the demand for certification among Lithuanian manufacturers, Sertika Director Ingrida Kusienė stated that there is indeed considerable demand for medical device certification from Lithuanian manufacturers. Once Notified Body status is obtained, the company expects to serve at least four clients per month during the initial stage.
According to I. Kusienė, the main challenges of the certification process include Lithuanian language requirements, the shortage of specialists, and the lengthy conformity assessment process, which can take around nine months.
Having a national Notified Body would reduce language and geographical barriers, allow faster responses to manufacturers’ needs, and provide more competitive service pricing. It would also strengthen Lithuania’s reputation as a provider of high-tech and expert services among medical device and in vitro diagnostic medical device manufacturers.
Future perspectives
Sertika’s efforts to become a Notified Body represent a step forward in strengthening Lithuania’s medical device and in vitro diagnostic medical device certification infrastructure.
The successful establishment of a national Notified Body would not only simplify certification procedures for local manufacturers but also increase the country’s competitiveness and innovation capacity in the healthcare sector. The NoBoCap project will also contribute to addressing the shortage of qualified specialists in Notified Bodies, promoting faster and more efficient medical device certification both in Lithuania and across Europe.
