RegDesk Regulatory Roundup

NHRA Guidance on MDR Transition Bahrain

NHRA Guidance on MDR Transition

The National Health Regulatory Authority (NHRA), a Bahrain’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the transition from Medical Directives to Regulations – the new regulatory framework recently adopted in the European Union.

The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in operations with medical devices in order to ensure compliance thereto.

At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. Furthermore, the authority reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.

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