MDR

Impact of EU MDR on MENA regulations

Carol Attieh, Chair of Mecomed’s Regulatory Committee and Senior Manager, GEM Regulatory Lead at Boston Scientific

The Middle East and North Africa (MENA) region is still considered a growth opportunity despite its political and economic instability for many multinational manufacturers of Medical Devices and IVD’s due to its unique mix of countries. One of the major challenges facing the industry is the diverse regulatory framework with different countries having their own sets of national requirements which constitutes a major administrative and economical investment.

Country national requirements in MENA are highly influenced by global jurisdictions such as EU. The application of the new EU Medical Device Regulations (EU MDR) in May 26, 2021, added another layer of complexity to the region as clear smooth transition plans were not always clearly defined by regulators to allow companies to manage their local approvals and thus manage their supply chain to ensure continuous patients access to treatment.

On December 9, 2022, at an Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council meeting of EU Health Ministers, the EU Commission announced it will be proposing an amendment of the transitional provisions of the Medical Device Regulation (EU) 2017/745 (MDR). The EU Commission is indicating that such amendments will likely extend the transitional provisions by 3 years for high-risk devices and 4 years for lower risk devices from May 2024. The extension of the deadline could be combined with an extension of the validity of MDD/AIMDD certificates and an abolition of the “sell off” period. The abolition of the “sell off” period could also apply to the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR). Ministers of Health at the EPSCO Council meeting recognized the urgent and serious implementation challenges of the MDR and the impact on availability of medical devices and quality of care for European patients. Draft amendments to the MDR and IVDR texts are expected in early January.

It is important for regulators in MENA to keep a close eye on the updates happening in Europe and immediately reflect any extensions of grace period nationally so that patients won’t suffer from lack of treatments.