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Regulation often stands at the crossroads of innovation and access in MedTech. While groundbreaking technologies are being developed at unprecedented speed, navigating complex compliance requirements remains one of the industry’s toughest hurdles. Malta Conformity Assessment (MCA) is stepping into this space with a clear mission — to enable safe, efficient, and timely access to medical technologies by strengthening regulatory capacity in Malta and the wider European market.
Salih Oğuz Savaş, Head of Notified Body at MCA, is responsible for overseeing the operations of the organisation’s Notified Body. “I design systems for operating the Notified Body and managing its activities,” he explained. “Our operational efficiency and expertise are critical in handling complex regulatory needs. By tracking state-of-the-art practices and regulatory updates, MCA positions itself early to support clients in a timely manner — ensuring innovative devices reach the market without unnecessary delay.”
MCA’s sponsorship of MedTech Malta 2025 underscores this mission. According to Savaş, the decision reflects the organisation’s commitment to strengthening Malta’s health-technology ecosystem and raising awareness of compliance with the EU Medical Device Regulation (MDR, Regulation (EU) 2017/745). The conference will create opportunities for knowledge-sharing across critical MDR areas such as clinical evaluation, technical documentation, and risk management.
“This collaboration will strengthen local capabilities and promote EU MDR compliance, positioning Malta as a more competitive and regulation-ready MedTech hub,” Savaş said.
Savaş will also join the panel “Navigating EU & US Regulations: Key Compliance Trends for MedTech” at the event. While MCA’s focus is on the EU, he noted that the greatest challenge for companies today lies in adapting to ever-changing regulations. “Rising costs are another important consideration,” he added. “But we encourage manufacturers to be brave enough to step in — it is not as difficult as it is often perceived.”
For companies entering the EU market, Savaş pointed to new pre-clinical and post-market clinical follow-up requirements as a key area of focus.
For MedTech startups, regulatory complexity often feels like an early stumbling block. Savaş believes there are practical ways to build compliance into innovation without losing momentum. “We recommend using digital solutions — they’re often perceived as tools for larger companies, but they can be extremely useful early on,” he said. “It’s also important to choose a notified body that is responsible and available for discussions.”
He emphasised the importance of early engagement with regulators and Notified Bodies:
“If you’re not prepared, projects can stall. Even if Notified Bodies cannot answer every question, early discussions clarify many issues and help companies move forward with confidence.”
As Malta gains recognition as an emerging MedTech hub, MCA sees its role as central to that growth. “We will elevate Malta to a prominent position on the global regulatory map by performing transparent, evidence-based assessments and strengthening the operational capacity of the local ecosystem,” Savaş shared. “Our aim is to make Malta a centre of excellence for safe and compliant innovation.”
Looking ahead, he expects digitalisation to play a defining role in the next 5–10 years. “We will be able to connect all types of regulatory data, creating structured and analysed insights that allow for better control and dedicated focus on necessary areas.” MCA is already investing in this direction, deploying digital solutions to connect clients and streamline conformity assessment processes.
Savaş is most excited about the interactive nature of his upcoming panel.
“What I’m looking forward to is a solutions-focused discussion where technical and clinical experts share real-world experiences translating EU MDR requirements into practice.”
MCA also aims to make a major announcement at the conference: the establishment of a new Notified Body soon to be appointed in Malta. “Our goal is to become a trusted destination for MedTech and innovation-driven medical device professionals — providing the regulatory support they need to meet EU requirements and obtain CE marking for their products.”
Savaş emphasised MCA’s core values: independence, technical competence, and patient safety. “Through MCA, we want to increase predictability and provide structured clarifications for certification processes, giving the local ecosystem the access it needs to the EU market.”
This November 12-14, the global MedTech community converges in Malta for three days of panels, networking, and pitches that bring together innovators, investors, regulators, and healthcare leaders.
If you haven’t yet secured your spot, this is your last chance to be part of the conversation, whether as a speaker, pitching startup, or partner. For more information, connect with us at [email protected].
