Regulatory
The recognition and reliance map
As global regulators pivot from bilateral pathways to structured reliance and recognition frameworks, medical device developers are rewriting their market-entry playbooks. Jim Banks maps out how international recognition and reliance programmes are compressing approval timelines and trimming duplication.
or decades, the global regulatory landscape for medical device approval has relied heavily on bilateral pathways, notably mutual recognition agreements (MRAs) between pairs of jurisdictions. MRAs have played an important role for at least 25 years, but regulators are now making greater efforts to put in place more flexible approaches to opening market access.
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The major MRA frameworks were established at the turn of the century. In the late 1990s, the US signed an MRA with the EU that included a sectoral annex on medical devices focused on recognising certain conformity assessments, and from the early 2000s MRAs for conformity assessment were established between the EU and countries such as Switzerland (entering into force in 2002), with further EU MRAs with Australia, New Zealand and Canada following.
These bilateral deals certainly opened up markets to new devices by having two nations accept each other’s conformity assessments, but they come with their own drawbacks. Regulatory standards and frameworks differ, so there have always been
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questions around divergence and equivalence. A lack of consensus on how much divergence is permitted before a device is no longer considered ‘substantially equivalent’ is a significant risk factor. Similarly, there are always differences in definitions. Disparities often exist between regions regarding high-risk classifications, for example, and this is particularly relevant now in the age of AI-enabled technologies. Furthermore, bilateral recognition can be complicated by regulatory divergence over time, a classic example being the UK in its post-Brexit era, with the Medicines and Healthcare products Regulatory Agency (MHRA) developing its own unique pathways that may not strictly align perfectly with EU or US requirements. Mutual recognition requires a high level of trust between trading partners, and this cannot be established overnight. Also, Notified Bodies in the EU – the independent, third-party organisations designated by EU Member States to assess the conformity of high-risk products – and their counterparts in the UK, known as Approved Bodies, have limited capacity, which can significantly slow
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