The Office for Life Sciences have published their latest updates. OLS Bulletin - 09 August These include updates on news, including regulatory updates, transitional guidance and events.
adminAugust 11, 2023
Following the phase out of ISO 13485 certificates to support applications for new In Vitro Diagnostic (IVD) medical devices, the TGA have published a guidance that helps sponsors to transition to using another form of manufacturer evidence to ensure ongoing regulatory compliance. The new guidance can be found here.
adminAugust 11, 2023
Please note this is an extract of the original bulletin. Using the UKCA marking* Page summary: Find out if you need to use the UKCA (UK Conformity Assessed) marking on products you manufacture or handle. Change made: Updated the ‘call to action’ banner before the main body of text, to list the sectors the CE marking will continue to apply…
adminAugust 11, 2023
The Office for Life Sciences have published their latest updates. OLS Bulletin - 31 July These include updates on news, including regulatory updates, transitional guidance and events.
adminAugust 4, 2023
The BSI CH/212 IVDs group is responsible for standardization in the field of in vitro diagnostics (IVDs). They have put forward a proposal to develop a new technical specification, ISO/PWI TS 8219: Sequencing and clinical application to infectious diseases. The document covers the essential requirements for advanced sequencing procedure for detecting the microbes directly, without the need for microbial culture.…
adminAugust 4, 2023
Please note this is an extract of the original bulletin. Medical devices: guidance for manufacturers on vigilance Page summary: Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA. Change made: Guidance updated to reflect the latest information regarding the MORE portal. COVID-19 test validation approved products Page summary: Find out which…
adminAugust 4, 2023
Please note this is an extract of the original bulletin. Find a professional to certify export health certificates Page summary: A list of organisations in England, Scotland and Wales that inspect and certify animals and animal products for export. The list does not include every certifier. Change made: Dorset Council Partnership is now changed to Dorset Council, with new contact…
adminAugust 4, 2023
Please note this is an extract of the original bulletin. Extended producer responsibility for packaging: who is affected and what to do Page summary: How UK organisations that supply or import packaging should comply with extended producer responsibility (EPR) for packaging. Change made: There’s been a decision to defer extended producer responsibility for packaging fees for one year. This update…
adminAugust 4, 2023
Please note this is an extract of the original bulletin. Code on Genetic Testing and Insurance: call for evidence* Page summary: We are seeking views on the Code on Genetic Testing and Insurance, to help us decide whether it may need to be revised to ensure it remains beneficial to both consumers and the insurance industry. Change made: First published.…
adminAugust 4, 2023
Please note this is an extract of the original bulletin. Approved manufacturers: conformity assessment Page summary: Apply to become or identify an approved manufacturer authorised to carry out conformity assessment. Change made: List of approved manufacturers updated. Approved verification: guidance and application form Page summary: Weights and Measures Act 1985 and subsequent Deregulation Order 1999 (as amended). Change made: Register…
adminAugust 4, 2023