Looking at the impact on the Middle East and Africa (MEA) region, where CE marking serves as a major regulatory reference supporting domestic registrations, the following challenges linked to the transition to EU MDR/IVDR can be highlighted:
(1) Change management challenges arising from differing interpretations of significant and nonsignificant changes and the lack of internationally harmonised guidance. In the absence of a harmonised framework and, in many cases, clear national guidance, identical changes may be assessed differently across jurisdictions, leading to inconsistent regulatory requirements, increased compliance burden, and delays in implementing device changes.
(2) Complex transition timelines and additional documentation requirements to demonstrate validity of Notified Body certificates (CE-certificates) for legacy devices
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(3) Making devices bearing a CE marking under the Directives available concurrently with devices ‘CE marked’ under the Regulations.
(4) Certificate of Free Sale –– lack of a harmonised format and unpredictable timelines for issuance of Certificates of Free Sale. The long and unpredictable timelines impact regulatory submission planning and often lead to delayed market access in the MEA countries requiring Certificate of Free Sale in regulatory or tender submissions.
Despite these challenges, MEA remains one of the regions where the CE marking and related regulatory documentation are used extensively to support registrations at the national level. In practice, the CE marking is used in various ways to support market access, from formal reliance, including recognition, to use of EU MDR/EU IVDR regulatory documentation and Certificate of Free Sale (CFS) in support of national registrations.