Jane Summerfield

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Articles

MHRA publishes guidance on to new UK medical device post-market surveillance requirements | JD Supra

Jan 23, 2025 | jdsupra.com | Jane Summerfield |Alexandra Wood

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a suite of guidance specifically designed to help medical device manufacturers understand and prepare for the new post-market surveillance (“PMS”) requirements expected to come into force on the 16th of June 2025.
MHRA opens consultation on future routes to market and IVDs under the UK medical device regulations | JD Supra

Nov 26, 2024 | jdsupra.com | Jane Summerfield |Alexandra Wood

The MHRA has opened a consultation on proposed future pre-market requirements for medical devices and in vitro diagnostic devices (IVDs) in Great Britain.
45 Healthy Activities for Kids & Families This Summer

May 31, 2024 | gethealthyu.com | Chris Freytag |Jane Summerfield

As a fitness expert I know the importance of keeping our bodies moving. Use my 45 fun and healthy activities for kids to keep your family active all summer long!These healthy activities are perfect for parents, grandparents, or any other family member who is looking to help build active and healthy habits with their kids. Modeling healthy choices at a young age will help encourage kids to stay more active as they get older.
UK MHRA publishes blueprint for the international recognition of medical devices | JD Supra

May 22, 2024 | jdsupra.com | Jane Summerfield |Alexandra Wood

The UK Medicines and Healthcare products Regulatory Agency (MHRA's) has published a Statement of policy intent: international recognition of medical devices outlining its proposal for the International Recognition Procedure (IRP) of medical devices in Great Britain.
2024 Life Sciences & Health Care Horizons | JD Supra

Apr 19, 2024 | jdsupra.com | Steve Abrams |Lynn Mehler |Jane Summerfield

While economic factors, including the high cost of capital, continue to keep our clients up at night, we also see signs of optimism in 2024. Against this fiscal backdrop, significant recent regulatory changes and those on the horizon will impact supply chain planning, commercial launch preparation, and pricing and reimbursement, making a cross-border perspective even more critical for achieving long term business goals. Please see full publication below for more information.
Future proofing

Nov 21, 2023 | pharmatimes.com | Penny Powell |Jane Summerfield

The UK regulatory environment for medicines and medical devices is undergoing significant changes, providing new opportunities. This includes enabling companies to apply for UK authorisation based on product authorisations from another trusted market, such as the US. This will allow medical devices companies additional time to transition to the future requirements and provide more detailed guidance to support compliance of AI and software medical devices.
UK MHRA to recognise medicine approvals including from FDA and EMA | JD Supra

Jun 8, 2023 | jdsupra.com | Jane Summerfield

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the introduction of new international recognitions routes for the approval of medicines that are already authorised in Australia, Canada, the European Union (EU), Japan, Singapore, Switzerland or the United States. The new routes are expected to be in place in the UK by the first quarter of 2024.
UK MHRA to recognise medicine approvals including from FDA and EMA

Jun 8, 2023 | lexology.com | Jane Summerfield

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the introduction of new international recognitions routes for the approval of medicines that are already authorised in Australia, Canada, the European Union (EU), Japan, Singapore, Switzerland or the United States. The new routes are expected to be in place in the UK by the first quarter of 2024.
MHRA Update on UK medical device legislation reform and transition | JD Supra

May 4, 2023 | jdsupra.com | Jane Summerfield

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an update on the timing of the reform of the current UK legislation, the Medical Device Regulations 2002 (UK MDR), and the transitional arrangements for CE marked devices on the Great Britain market. CE Mark transitionUnder the current UK MDR, CE marked devices can be placed on the market in Great Britain until 30 June 2023.