The Importance of Certification
Certification of medical devices and in vitro diagnostic medical devices is critical for 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 lacks its own Notified Body to certify these devices. Consequently, the certification role is fulfilled by Notified Bodies from other EU countries. The importance of Notified Bodies is substantial, as they conduct thorough evaluations to ensure that all medical devices meet strict safety standards before being placed on the Lithuanian and EU markets.
The Need for Notified Bodies: Challenges and Opportunities
With advancements in science and technology, the demand for medical devices and the need for certification is growing. Efforts to strengthen the capacity of Notified Bodies, promote collaboration, and simplify processes are essential for effectively addressing these challenges. Lithuania’s reliance on Notified Bodies from other EU countries poses challenges, such as communication and coordination difficulties, as well as high workloads for these bodies. However, these challenges also present opportunities. If Lithuania establishes its own Notified Body, it could enhance the certification capacity within the EU and speed up the certification process, especially for small and medium-sized enterprises (SMEs) or startups. By developing expert infrastructure, Lithuania could become a reliable center for medical device certification within the EU.
Enhancing the Capacity of Notified Bodies
Not only Lithuania but all of Europe faces challenges with medical device certification and the high workloads of Notified Bodies. The European Commission is preparing measures to address these issues. According to Diana Vertelkienė, head of the health technology cluster “iVita”, “For the second year, our cluster, along with EU partners, is carrying out the NoBoCap project (Notified Body Increased Capacity), aimed at expanding the capacity of Notified Bodies to enhance or provide the necessary qualifications to potential employees.” Through the project, training is provided to attract new, trained, and qualified employees to Notified Bodies, partially addressing the shortage of skilled personnel.
Another important part of the project is the NoBoCap community, which brings together various organizations working in the fields of medical and health technology. Members are united by common challenges related to the implementation of new regulations for medical and in vitro diagnostic devices and the integration, use, and regulation of innovative technologies, such as artificial intelligence, in medical devices. The community’s partners contribute with their knowledge, experience, and consulting services to help innovators meet ISO 13485 quality standard requirements and accelerate the certification process.
In Lithuania, participants from the health technology ecosystem have already joined the NoBoCap community, including Smart Health DIH, Tech-Park Kaunas, Biomapas, 2AM Health and Sertika, a company aspiring to become a Notified Body. According to D. Vertelkienė, this membership will be especially beneficial for “Sertika” as it will help the company receive the necessary support and knowledge on regulatory aspects for medical and in vitro diagnostic devices and facilitate the recruitment of new potential employees and essential experts.
SERTIKA Efforts to Become a Notified Body
Lithuania may soon see a significant change in the certification sector – JSC “Sertika” is making substantial efforts to become a Notified Body that could audit medical devices and, later, in vitro diagnostic medical devices. This would be an important step in strengthening Lithuania’s medical device market and its position in the European healthcare sector. To gain Notified Body status, “Sertika” is preparing internal procedures, seeking specialists in biocompatibility, software, clinical trials, and sterilization assessment, and conducting team training to prepare for the evaluation process. The application to become a Notified Body will be evaluated over approximately a year.
Responding to the question of Lithuanian manufacturers’ demand for medical devices and in vitro diagnostic devices certification, “Sertika” director Ingrida Kusienė noted that there is considerable demand for certification from Lithuanian manufacturers. If they receive Notified Body status, the company expects at least four clients per month in the initial stage. According to I. Kusienė, the main challenges in the certification process are the requirements for the Lithuanian language, a shortage of specialists, and the lengthy compliance assessment process, which can take about nine months.
With a national Notified Body, language and geographic barriers would be reduced, allowing for a quicker response to manufacturers’ needs and a competitive service price. This would also increase Lithuania’s reputation as a provider of high-tech and expert services among manufacturers of medical and in vitro diagnostic devices.
Future Prospects
Sertika’s efforts to become a Notified Body mark a step forward in strengthening the certification infrastructure for medical and in vitro diagnostic devices in Lithuania. The successful establishment of a Notified Body would not only ease the certification process for local manufacturers but also enhance the country’s competitiveness and innovation in the health sector. The NoBoCap project will also help address the shortage of skilled personnel in Notified Bodies, promoting faster and more efficient certification of medical devices both in Lithuania and across Europe.
