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

Table of Contents

• ↓ Medical technologies around you
• ↓ How our sector is regulated
• ↓ Our contribution to the EU agenda
• ↓ EU MDR/IVDR transition: a Middle East and Africa focus
• ↓ Joint declaration for a bold FP10: investing in RD&I to boost European competitiveness
• ↓ Smarter MDR and IVDR oversight safeguarding access to safe and innovative medical technologies
• ↓ Top Alternatives to medtecheurope.org

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"Our Priorities MedTech Europe strives to support our dynamic sector in meeting the needs of patients and health systems. To achieve this, we focus on engaging with healthcare stakeholders on key issues from regulations and market access to digital health and procurement, among others."

"Sector Groups MedTech Europe sector groups bring together company experts to drive forward key healthcare domains, helping to address issues facing these sectors and shaping their future. We have dedicated groups focused on cardiovascular health, cancer, diabetes, wound care, orthopaedics, robotic-assisted surgery and AMR/HAI."

"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."

Key Topics & Focus Areas for medtecheurope.org:

Medical technologies around you

How our sector is regulated

Our contribution to the EU agenda

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

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

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