EU MDR/IVDR transition: a Middle East and Africa focus

In 2017, the European Union adopted the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) with the aim of creating a robust, transparent and sustainable regulatory framework for medical devices and IVDs that is recognised internationally. The modernisation of the European system introduced major updates in the documentation and evidence requirements, effectively leading to more information being available about medical devices and IVDs. This does not change the use, effectiveness, performance or safety profile of the devices and as such should not have a particular impact on international registrations since all jurisdictions allow additional information to be provided with medical devices and IVDs.

However, following a few years since the application of the Regulations, MedTech Europe and Mecomed took a closer look at what is the international relevance of EU MDR/IVDR and the impact on international registrations, zooming in on the region that is characterised by a fast-evolving and dynamic regulatory landscape, and where CE marking plays an important role in supporting domestic registrations – the Middle East and Africa.

The assessment shows that the impact of the transition to EU MDR/IVDR extends well beyond the EU market as CE marking remains widely used to support medical device and IVD registrations in international markets. The extent of the impact varies from jurisdiction to jurisdiction depending on their specific regulatory requirements and the degree to which CE marking plays a role in supporting domestic market access.

Based on the experience in the Middle East and Africa (MEA) region, this paper identifies the following challenges with implications for international registrations, linked to the transition to EU MDR/IVDR:

• Different approaches to handling of significant and non-significant changes
• Complexity in demonstrating eligibility to benefit from the extended transition timelines to non-EU regulators
• Simultaneous availability on the market of devices bearing CE marking under EU Directives and EU Regulations
• Lack of a harmonised format and unpredictable timelines for issuance of Certificates of Free Sale

Recognising that the majority of changes arising from the transition to the EU MDR/IVDR are administrative in nature, or result in the provision of additional information, and do not adversely affect a device’s safety, performance, or risk profile, this paper identifies a set of key considerations to support a harmonised and proportionate regulatory approach. Such an approach should maintain high standards of patient safety while avoiding unnecessary barriers to the continued availability of compliant medical devices.

This includes the acceptance of devices certified under the EU Medical Devices Directive (MDD), Active Implantable Medical Devices Directive (AIMDD), and In Vitro Diagnostic Medical Devices Directive (IVDD) alongside devices certified under the EU MDR/IVDR, with equal regulatory and procurement status throughout the transition period. It also calls for stronger collaboration and communication among local and international stakeholders, particularly between EU and non-EU regulators, to promote regulatory convergence and consistency. Together, these measures are essential to achieving greater regulatory agility while safeguarding the continuity of supply and ensuring patients retain timely access to safe, performant, and life-saving medical technologies.

Read our joint paper below.