Regulatory

November 18, 2022 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Latest UKCA extensions do not apply to medical devices

This includes: The General Product Safety Regulations 2005 Supply of Machinery (Safety) Regulations 2008 Electromagnetic Compatibility Regulations 2016 Pressure Equipment Safety Regulations 2016 Electrical Equipment (Safety) Regulations 2016 Simple Pressure Vessels (Safety) Regulations 2016 Radio Equipment Regulations 2017 These timelines have been extended for 12 months to allow extra time for compliance. Importantly, these timeline changes do not impact medical…
Read More
September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Regulations: ecodesign of energy-consuming products – Regulatory Affairs Newsletter #1

Guidance for manufacturers, their authorised representatives and importers. Change made: Declaration of Conformity template added. Other pages commonly used European Commission updates MedTech Europe updates HSE eBulletins UKRI updates Home Office updates Office for Life Sciences bulletin Cabinet Office weekly update (extract of original bulletin) Environmental Agency weekly update (extract of original bulletin) MDCG updates Could consider Upcoming regulatory or…
Read More
September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

MHRA innovation case studies – Regulatory Affairs Newsletter #1

Case studies demonstrating how MHRA has helped a number of companies navigate the regulatory processes for innovative new medicines and medical devices. Change made: Added ‘Horizon Scanning Case Study: Point of Care manufacture’ to the collection.
Read More
September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Innovation Accelerator – Regulatory Affairs Newsletter #1

Provide innovators and developers of innovative products access to MHRA scientific expertise, regulatory guidance and an enhanced advice and signposting service. Change made: First published.
Read More
September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Horizon Scanning Case Study: Point of Care manufacture – Regulatory Affairs Newsletter #1

Horizon scanning at the MHRA leads to a proposed new framework to enable the supply and increase in the availability of innovative new medicinal products made at the point of care to patients. Change made: First published.
Read More
September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

MHRA weekly update – Regulatory Affairs Newsletter #1

Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or cancellation. Change made: Updated ‘Open List’
Read More
September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Health and Care Act 2022: adult social care provider information provisions – Regulatory Affairs Newsletter #1

Guidance for adult social care providers to comply with information provisions under section 99 and section 100 of the Health and Care Act 2022. Change made: First published.
Read More
September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Coronavirus Act report: May 2022 – Regulatory Affairs Newsletter #1

The thirteenth two-monthly report on which powers in the Coronavirus Act 2020 are currently active. Change made: Added a correction slip to the report, detailing revisions to the document on pages 4 and 11.
Read More
September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Businesses approved to export to the EU – Regulatory Affairs Newsletter #1

Page summary: Use the lists to check your business in Great Britain (England, Scotland and Wales) or one of the Crown Dependencies (Jersey, Guernsey and Isle of Man) is approved to export to the EU, and find out what your TRACES number is.   Change made: Updated the lists of businesses approved to export to the EU.
Read More
September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

BIVDA updates – Regulatory Affairs Newsletter #1

Places are filling up for the BIVDA Joint Working Party and Regulatory Affairs Seminar! If you are looking to attend Working Party meetings or the Regulatory Affairs Seminar, we encourage you to register as soon as possible to prevent disappointment. The agenda for these are being finalised, but the seminar is aiming to cover: Summary of what is going on…
Read More
September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Summary – Regulatory Affairs Newsletter #1

The BIVDA Joint Working Party and annual Regulatory Affairs Seminar is approaching on 12-13 October. Members are encouraged to book tickets as soon as possible to prevent disappointment – places are filling up fast!
Read More