MDR and IVDR

MedTech Europe's position on the revision of the Medical Devices Regulation & In Vitro Diagnostics Regulation

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Posted on 31.08.2026

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.

Joint declaration for a bold FP10: investing in RD&I to boost European competitiveness

Europe stands at a decisive juncture. The Draghi report on European Competitiveness has laid bare a stark reality: Europe’s productivity growth has stalled, its innovation gap with the U.S. and China is widening, and the continent risks a slow but irreversible decline in its economic standing. At the same time, the Competitiveness Compass and the EU’s political guidelines place research, development and innovation (RD&I) at the heart of Europe’s strategy to reverse this trend. MedTech Europe, along with 85 European associations representing key RD&I stakeholders, fully endorse this diagnosis and urgently call on EU Institutions to act with commensurate ambition in designing and funding the next Framework Programme for Research and Innovation (FP10). In this joint declaration, we call on EU institutions to allocate a substantially increased budget to FP10; reinforce collaborative and industry-driven RD&I; and ensure that FP10 together with ECF support the full RD&I continuum.

Smarter MDR and IVDR oversight safeguarding access to safe and innovative medical technologies

MedTech Europe, together with six other associations, developed a joint position paper highlighting how the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) simplification proposal provide a more proportionate approach to life-cycle oversight. Europe needs a regulatory system that protects patients while supporting innovation and competitiveness. The proposed simplification of the MDR and IVDR offers a more proportionate and efficient approach to life cycle oversight. While the regulations have strengthened safety, they have also increased complexity, costs and administrative burden, particularly for small and medium-sized enterprises. This risks reducing the availability of essential medical technologies. The European Commission’s proposal introduces a more targeted, risk-based model. By removing duplicative processes and focusing oversight where risks are highest, it enables earlier detection of safety issues and better use of regulatory resources. Notified bodies and authorities can prioritise meaningful surveillance rather than routine tasks, while core responsibilities across the product life cycle remain unchanged. A simpler system does not reduce safety. It strengthens it by focusing effort where it matters most, supporting innovation and ensuring patients continue to benefit from safe and effective medical technologies. Read our joint position paper below.

About us

MedTech Europe is the European trade association representing the medical technology industries, from diagnosis to cure.

We represent Diagnostics and Medical Devices manufacturers operating in Europe. There are more than 2,000,000 products, services and solutions currently made available by the medical technology industry. These range from bandages, blood tests and hearing aids to cancer screening tests, pacemakers and glucose monitors.

Our sector employs more than 930,000 people. There are more than 38,000 medical technology companies in Europe, of which 90% are SMEs.