With the adoption of the Regulation (EU) 2017/745 (MDR), the regulatory framework for medical devices has changed significantly. The main objectives of this Regulation are to “establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation”. However, despite the significant effort from the European Commission and the Medical Devices Coordination Group (MDCG), there is a growing concern for the readiness of the sector on 26 May 2024, when the transitional provisions allowing medical devices certified under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) and the Medical Device Directive 93/42/EEC (MDD) to be placed on the market will expire.
COCIR members, representing medical device manufacturers in medical imaging, radiation therapy and digital health sectors, are well advanced in MDR certification. However, concerns remain.
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