MedTech Europe and Mecomed Highlight MDR and IVDR Impact on International Registrations in MEA

MedTech Europe and Mecomed have published a document addressing the impact of the EU Medical Device Regulation, Regulation (EU) 2017/745, and the In Vitro Diagnostic Medical Device Regulation, Regulation (EU) 2017/746, on international registrations, with a specific focus on the Middle East and Africa region.

The document provides considerations for a more harmonised approach to handling regulatory changes arising from the transition to the EU MDR and EU IVDR.

Background

The document recalls that the EU adopted the MDR and IVDR in 2017 to create a more robust, transparent and sustainable regulatory framework for medical devices and IVDs.

The MDR replaced the Medical Devices Directive and the Active Implantable Medical Devices Directive and became applicable on 26 May 2021. The IVDR replaced the IVD Medical Devices Directive and became applicable on 26 May 2022.

Impact Beyond Europe

MedTech Europe and Mecomed note that the transition to the EU MDR and IVDR has effects beyond Europe because CE marking is widely used to support medical device and IVD registrations in international markets.

The impact varies across jurisdictions depending on local regulatory requirements, and changes to regulatory documentation may differ from device to device.

Key Challenges in the MEA Region

The document identifies several challenges linked to the transition to the EU MDR and IVDR in the Middle East and Africa region.

These include differing interpretations of significant and non-significant changes, lack of harmonised guidance, complex transition timelines, additional documentation requirements to demonstrate CE certificate validity, concurrent availability of devices CE marked under the Directives and Regulations, and challenges related to Certificates of Free Sale.

Despite these challenges, the document states that CE marking and related regulatory documentation continue to be used extensively in the MEA region to support national registrations.

Change Management

The document highlights that the transition to the EU MDR and IVDR may lead to changes in device classification, instructions for use, labelling or intended purpose.

Manufacturers are expected to assess the effect of such changes on a case-by-case basis using a risk-based approach, distinguishing largely administrative changes from those that may affect safety, performance or risk profile.

According to the document, changes arising from the transition may result in notification, variation, a new submission, or no additional action, depending on local requirements.

Need for a Harmonised and Risk-Based Approach

MedTech Europe and Mecomed recommend a pragmatic and risk-based approach to managing changes arising from the EU MDR and IVDR transition to avoid unintended disruption to device supply.

The document states that changes that do not affect device safety and/or performance, such as administrative changes arising only from the transition to the EU MDR and IVDR, should be considered non-significant or minor changes. Changes that could reasonably be expected to affect safety and/or performance should be considered significant.

Extended CE Certificates and Legacy Devices

The document also discusses the complexity created by extended transition timelines and additional documentation requirements to demonstrate validity of Notified Body certificates.

It explains that EU amending Regulations introduced transitional provisions allowing manufacturers to continue producing certain legacy devices under specific conditions, even where the original CE certificate date under the Directives has expired.

The document notes that, in the EU, manufacturers can use a self-declaration to demonstrate eligibility for an extended transition period, while a Notified Body confirmation letter may support this but is not a mandatory legal requirement.

In the MEA region, however, additional documents are often requested, such as Notified Body confirmation letters, EU Certificates of Free Sale, or written and signed contracts between the Notified Body and manufacturer, which can increase burden and delay access.

Concurrent Availability of Directive and Regulation Devices

The document emphasizes that, in the EU, devices CE marked under the Directives and eligible for transition may coexist with devices CE marked under the MDR or IVDR.

During the transition period, both categories have the same legal status and may be simultaneously placed on or made available on the EU market, provided applicable conditions are met.

MedTech Europe and Mecomed recommend that devices CE marked under the MDD, AIMDD or IVDD and those CE marked under the MDR or IVDR be permitted to be placed on the market concurrently with equal legal status throughout the applicable transition period.

Certificates of Free Sale

The document identifies Certificates of Free Sale, or CFS, as critical documents in regulatory and market access pathways in many MEA countries.

However, variability in CFS content, lack of a standardized format across the EU, and long or unpredictable issuance timelines can complicate regulatory submission planning, delay device registration, limit tender participation and delay patient access.

Main Recommendations

The document recommends measures to reduce supply disruption and administrative burden, including:

• categorizing changes using a risk-based framework;

• allowing multiple non-significant changes for one product in a single submission;

• enabling immediate implementation of non-significant changes without prior regulatory approval;

• using fast-track review for significant changes where approval is required;

• providing reasonable transition periods;

• allowing coexistence of devices CE marked under the Directives and Regulations;

• coordinating with customs authorities;

• using EUDAMED information for devices compliant with MDR or IVDR.

The document also refers to existing references such as GHWP change management guidance, WHO’s Global Model Regulatory Framework and MDCG guidance, while noting that an IMDRF guidance on change management would be desirable as an internationally recognised reference.

Impact on Medical Device and IVD Manufacturers

For medical device and IVD manufacturers active in the Middle East and Africa, the document is highly relevant because CE marking and EU regulatory documentation remain important tools for supporting registrations and market access.

Manufacturers should pay particular attention to:

• changes arising from MDR and IVDR transition;

• classification, IFU, labelling and intended purpose changes;

• significant versus non-significant change assessment;

• local variation and notification requirements;

• extended CE certificate documentation;

• use of manufacturer self-declarations;

• Notified Body confirmation letters;

• Certificates of Free Sale;

• coexistence of legacy and MDR/IVDR-compliant devices;

• supply continuity and customs coordination;

• regulatory planning across MEA jurisdictions.

For manufacturers, the key message is that MDR and IVDR transition management should be handled through proportionate, harmonised and risk-based regulatory processes to avoid unnecessary administrative burden and protect continuity of patient access.