MHRA Guidance Regulating medical devices from 1 January 2021

Guidance: Regulating medical devices from 1 January 2021
Medicines and Healthcare products Regulatory Agency 1 September 2020

• What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets from 1 January 2021.
• This guidance provides information on how the UK system will operate, including for:
• Getting your device certified
• Conformity marking your device
• Registering your device with the MHRA

• See commentary in HSJ here.

Medicines and Medical Devices Bill

Medicines and Medical Devices Bill
DHSC 13 February 2020

• The Medicines and Medical Devices Bill will allow:
• NHS hospitals to use innovative, personalised medicines for unique cancers and diseases,
• increase the range of professions able to prescribe medicines in low-risk circumstances, reducing unnecessary GP appointments
• introduce new regulations on medical devices, such as pacemakers, breast implants and ultrasound imagers, to ensure patient safety
• Read the House of Commons Library briefing.

Queen’s Speech background paper

Queen’s Speech background paper
House of Commons Library Briefing 14 October 2019

• Proposed new legislation on SUPPORTING THE NHS
• NHS Long Term Plan
• Health Service Safety Investigations Bill
• Medicines and Medical Devices Bill
• Adult social care
• Mental health reform

Intellectual property and Brexit

Intellectual property and Brexit
Intellectual Property Office 10 October 2019

• Guidance on trade marks, designs, patents right law, and exhaustion of IP rights after Brexit.

Machine learning as a medical device

Machine learning as a medical device
In Algorithms as medical devices Chapter 3
PHG Foundation September 2019

• This chapter considers whether machine learning techniques pose a novel problem for medical device regulation.

NHS Long-term Plan: legislative proposals

NHS Long-term Plan: legislative proposals
Health and Social Care Select Committee 24 June 2019

• The Committee found that NHS England and NHS Improvement proposals  for legislative changes to the Health and Social Care Act 2012 in many cases continue the direction of travel towards a more integrated collaborative and placed-based system. It broadly supports NHS England and NHS Improvement’s proposals to:
• to promote collaboration and lessen the role of competition in the NHS, especially the proposal to repeal section 75 of the Health and Social Care Act 2012 and revoke the regulations made under it;
• remove the Competition and Market’s Authority’s role in mergers of foundation trusts;
• ease the burden procurement rules have placed on the NHS, ensuring commissioners have discretion over when to conduct a procurement process, with the inclusion of a ‘best value’ test; and
• allow greater flexibility locally over payment systems.
• However the Committee comments that the plans remains too NHS-centric rather than looking at the wider system with which it seeks to integrate and that the Department of Health and Social Care, NHS England and NHS Improvement should be clearer about the roles local government, the voluntary and community sector and independent providers should play in the future of the NHS.
• Themes of the report are competition, integrated care, NHS leadership, and Cross-party endorsement of legislative proposals

Some Legal Implications of the NHS Long Term Plan

Some Legal Implications of the NHS Long Term Plan
Hempsons 19 February 2019

• In order to improve access to services, the Long Term Plan (LTP) sets out ambitions for better integration between primary, secondary and community services for patients. 
• This note highlights some of the legal implications of the LTP in particular around procurement, competition, workforce, and Primary Care Networks / Sustainability and Transformation Partnerships / Integrated Care Systems.

Amending the 2012 Act: can it be done?

Amending the 2012 Act: can it be done?
Kings Fund 25 October 2018

• This short piece identifies some of the main complaints about how the Health and Social Care Act 2012 operates; outlines some of the implications should attempts be made to amend it; and asks how far progress could be made within the existing legislation.
• Speaking to the Public Accounts Committee 2018 Simon Stevens has said that the question will inevitably arise as to whether there are aspects of the current legislation that, if amended, ‘would accelerate our progress’. He indicated that, once the long term plan is published, "the current intention is to produce ‘between November and Easter’ and ‘with colleagues across the NHS’ options for legislative change."

Myths Associated with the GDPR

Myths Associated with the GDPR [blog]
Naomi Korn Associates 23 May 2018

• The changes introduced by GDPR to UK data protection law are modest and many of the emails asking if you wish to continue to receive communications were unnecessary.
• "The facts about when you may process, i.e., obtain, record, manage, structure, store, amend or delete, or disseminate personal data ...law has hardly changed in this regard."
• The blog sets out the six reasons why you are allowed to process personal data.