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MHRA: proposed framework for international recognition of medical devices
This initiative signals an important step towards a new regulatory framework for medical devices in the UK that protects public health, ensures access to MedTech innovations, and maintains an attractive market for the industry. The framework ensures safe access to quality-assured medical devices, reduce the duplication of assessments by comparable…
The New Regulatory Framework - UK
The MHRA previously confirmed that it would use expertise and decision-making from comparable regulator countries (CRC), (CRC countries are the EU, US, Australia, and Canada), to bring medical devices to the UK market. Within the system of recognition and trust, the so-called Reliance Route for Market Authorization (MA) framework, the…
IVDR Transition Timelines Extended
Regulation (EU) 2024/1860 was published on June 9, 2024, in the Official Journal of the European Union (OJEU) with immediate effect. The amending Regulation provides extra time to conduct the conformity assessment of IVD’s needed for a CE certificate or an issued DoC. This Amending Regulation extends the IVDR transition…
UKRP-services
The UK medical device regulatory system is independent of the European Economic Area (EEA). All medical device manufacturers will need to follow UK laws for (in vitro) medical devices, based on the EU regulations EU-MDR 2017/745 and EU-IVDR 2017/746. All non-UK manufacturers must have a UK-based UK Responsible Person…
BREXIT impact
How medical devices are currently regulated All medical devices are subject to EU legislation, which requires a manufacturer to place a CE mark on their product to attest compliance to applicable standards. Medical devices are regulated under Directive 90/385/EEC on active implantable medical devices (AIMDD), Directive 93/42/EEC on medical devices…
MDR and IVDR finally published (May 4th, 2017)
European Medical Device Regulations 2017/745 (MDR) and In Vitro Diagnostic Regulations 2017/746 (IVDR) are published May 5, 2017 in the Official Journal of the European Union (OJEU), May 4th, 2017. The MDR will replace the Active Implantable Medical Devices Directive (AIMD 90/385/EEC) and the Medical Devices Directive (MDD 93/42/EC), while…