New European Manual on Borderline and Classification for Medical Devices and IVDs Issued
European Commissioners have published a highly anticipated new version of the Manual on Borderline and Classification for medical devices under the Medical Devices Regulation (MDR) and for in vitro diagnostic (IVD) devices under the In Vitro Diagnostic Med
New US FDA Guidance Covers Computer Software Assurance for Medical Device Production
The US Food and Drug Administration has published new guidance recommending appropriate risk-based computer software assurance processes related to medical device production and quality systems in order to raise device manufacturing quality levels.
US FDA Sets Emergency Use Authorization Policy for Monkeypox Diagnostic Test
New guidance from the US Food and Drug Administration establishes emergency market access for in vitro diagnostic (IVD) tests to diagnose monkeypox infections.
UK Medical Device Regulators Extend UKCA Transition Plan by One Year
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has officially delayed implementation of planned medical device regulations by 12 months in order to avoid potential supply disruptions and allow more time for preparing necessary systems.
European MDCG Clarifies Market Access Requirements for Legacy Devices Under Article 97 MDR
An MDCG position paper explains the process for obtaining permission to sell legacy devices in European Union member states according to Article 97(1) MDR
Medical Device Registration in Malaysia
Emergo by UL can help your medical device registration effort with the Medical Device Authority (MDA) for approval to sell on the Malaysian market.
European Commission Proposes Extending MDR, IVDR Transition Periods
European regulators have put forth amendments to MDR, IVDR compliance timelines to avoid medical device and IVD supply disruptions
FDA Finalizes Which Clinical Decision Software Functions it Regulates
The FDA has clarified the criteria for which clinical decision software it regulates as a medical device.
South Korea Rules on Emergency Production and Distribution of Medical Products
South Korean regulators rule on emergency medical product manufacture and distribution.
Singapore’s HSA to Commence Phase I Implementation of UDI Labeling in November 2022
Singapore’s HSA begins implementing Phase I of its UDI system requirements.