Malta Conformity Assessment: building a new regulatory gateway to the European MedTech market

Access to Notified Body capacity remains one of the most pressing challenges facing the European medical device industry today. Since the introduction of the EU Medical Device Regulation (MDR) (EU) 2017/745, manufacturers across the continent have faced longer timelines, greater documentation demands, and a shrinking pool of Notified Bodies able to review their applications. For companies of every size, from large multinational manufacturers to small and medium-sized innovators, timely and predictable access to certification is not simply an administrative concern. It is often the difference between bringing a life-improving technology to patients on schedule or facing costly delays that ripple across an entire product roadmap.

It is against this backdrop that Malta Conformity Assessment (MCA) has emerged as a significant new player in the European regulatory landscape. MedTech World spoke with Salih Oğuz Savaş, Head of Notified Body, and Seval Aktaş, Medical Devices Sales Unit Manager, at MCA, about the organisation’s mission, its technical scope, and its broader vision for supporting medical device manufacturers as they navigate an increasingly complex regulatory environment.

A notified body built for a complex regulatory landscape

MCA is Malta’s first MDR Notified Body, operating under the designation number Notified Body 3132. Recognised by the European Commission and the Malta Medicines Authority, MCA was established with the vision of strengthening regulatory capacity both in Malta and across Europe.

MCA’s core function is to issue CE Certificates for medical devices, enabling manufacturers to bring safe, effective and innovative technologies to the European market. According to Savaş, the organisation was built around three guiding principles: technical expertise, regulatory excellence, and digitalisation.

By combining these elements, MCA aims to deliver certification services that are not only efficient but also transparent, a priority for manufacturers who increasingly cite unpredictability and long timelines as major pain points in the MDR certification process. MCA’s digitalised assessment processes are designed to reduce friction in this journey, while its close alignment with evolving European regulatory requirements and emerging technologies helps manufacturers approach certification with greater confidence.

More than certification: a partner across the product lifecycle

While conformity assessment remains at the core of MCA’s work, the organisation positions itself as more than a certification body. MCA is actively involved in education, training, and stakeholder engagement, working alongside industry partners to strengthen the wider MedTech ecosystem.

This extends to a broader commitment to improving regulatory predictability and facilitating innovation, goals that go beyond the certification transaction itself and reflect a lifecycle oriented approach to supporting manufacturers, from early development through to post market activities.

A broad and growing technical scope

MCA’s designation scope is notably wide ranging, spanning both active and non-active medical devices. This includes:

• Software and digital health technologies
• Diagnostic, monitoring and imaging devices
• Respiratory and anaesthesia devices
• Dialysis and extracorporeal circulation systems
• Cardiovascular, neurovascular, orthopaedic, dental and soft-tissue implants
• Catheters and guidewires
• Wound care products
• Ophthalmic and ENT devices
• Rehabilitation and patient positioning systems
• Medical gas supply systems
• Sterilisation and disinfection technologies
• Surgical instruments
• Substance-based medical devices
• Devices for the processing and preservation of human cells, tissues and organs

Beyond these device categories, MCA also holds horizontal technical competencies covering areas such as sterile devices, reusable surgical instruments, software-controlled devices, devices incorporating medicinal substances, devices with measuring functions, systems and procedure packs, custom-made Class III implantable devices, and biologically active or absorbable materials. Its expertise further extends to products manufactured using advanced technologies, including biotechnology, chemical processing, cleanroom manufacturing and electronic systems.

In addition to MDR CE certification, MCA also supports manufacturers with medical device testing services, including testing for biomechanical implants, further broadening the practical support it can offer companies throughout development and certification.

Positioning Malta as an emerging MedTech hub

As Malta works to strengthen its profile as a growing hub for medical technology, MCA sees itself playing a central role in connecting both local and international manufacturers with the European market. For Savaş and Aktaş, this means anchoring MCA’s work in independence, technical competence, patient safety and innovation, values the organisation hopes will position it as a trusted regulatory partner for medical device companies worldwide.

As the European MedTech sector continues to grapple with capacity constraints among Notified Bodies, MCA’s emergence adds a new access point for manufacturers seeking MDR certification, while reinforcing Malta’s ambitions within the broader European regulatory framework.

Up next: MedTech World Europe 2026 | Malta

MedTech World Europe 2026 will bring the global MedTech community to Malta from 11 to 13 November 2026, at the historic Mediterranean Conference Centre (MCC) in Valletta. The biggest MedTech World event yet, this three-day gathering will bring together more than 2,000 industry leaders, innovators, investors and healthcare professionals to discuss the regulatory, commercial and technological developments shaping the sector. For manufacturers, regulators and MedTech stakeholders looking to connect, exchange insights and explore new opportunities across the European market, MedTech World Europe 2026 provides a timely opportunity to be part of the conversation. Book your ticket now and join us in Valletta this November.