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Phthalates Benefit-Risk Guidelines
The EU's Medical Devices Regulation (MDR) addresses requirements for using CMR and/or ED substances in Chapter II Section 10.4 of Annex I (MDR). The commission’s Scientific Committee on Health, Environmental, and Emerging Risks (SCHEER) finalized its revised phthalates benefit-risk assessment guidelines on June 17, 2024. Under the MDR, these guidelines…
(EU) Regulation 2024/1689, the so-called "AI Act" (AIA), and the MDR/IVDR
Software (including AI) for medical purposes is regulated in Europe and the United Kingdom as a medical device. It requires comprehensive assessment before being placed on the EU and UK market under Medical Device Regulations (MDR) and the EU In Vitro Diagnostic Medical Devices Regulation (IVDR). The European Union (EU) has introduced new legislation on…
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…