Session 2019-21
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Other Bills before Parliament




House of Commons


Notices of Amendments


given up to and including


Monday 9 March 2020


New Amendments handed in are marked thus Parliamentary Star


Parliamentary Star - whiteAmendments which will comply with the required notice period at their next appearance


Amendments tabled since the last publication: 1


Public Bill Committee


Medicines and Medical Devices Bill




This document includes all amendments tabled to date and includes any


withdrawn amendments at the end. The amendments have been arranged in the


order in which they relate to the Bill.



Ms Marie Rimmer




Parliamentary Star    

Clause  2,  page  2,  line  23,  at end, insert—



the origin and treatment of human organs used in the process of


developing or manufacturing medicines”



Anne Marie Morris




To move the following Clause—



“National Medical Devices Registry and governance



The Secretary of State must by regulations establish a national registry of medical


devices the purpose of which shall be—



to record—


Notices of Amendments: 9 March 2020                     



Medicines and Medical Devices Bill , continued



every medical device implanted in, or



inserted into



a patient.



to consolidate existing English registries and require their owners to


migrate their data to such a registry, ensuring all GDPR consents have


been obtained or deemed obtained and to organise such data in a common


and consistent way.



In designing such a registry, the Secretary of State must take account of existing











protocols; and



quality standards


to enable better international learning, collaboration, health outcomes, research


and product improvement globally.



For the purposes of subsection (1), every device shall be required to have its own


unique identifier. Manufacturers of such devices or components of such devices


shall be required to provide the identification data of every device or device


component to the registry on manufacture, and on its sale or change of ownership.



Clinical Commissioning Groups in England shall require all health service


providers using medical devices covered by this section to put in place a system


to require NHS trusts to record the clinical use of any such device or component


of such devices on the registry when used in their population. The records must





the date of use,



the nature of the procedure,



the clinicians performing the procedure



clinical information about the condition of the patient at the point of use


and thereafter on any future reviews of the performance of the device,





health outcomes, and information on how such records will be collected


in future.



Every health service provider whose clinicians are implanting or inserting


medical devices shall establish its own procedure and protocols to record the data


as prescribed in this Act and by the Secretary of State in regulations made under


this Act, which shall be consistent, efficient and integrated into the health care


pathway for the medical procedure in question.



The Secretary of State shall by regulation establish a stakeholder consultation


group with which to consult on the governance of any registry established under


subsection (1). The stakeholder group which must include—



patients and patient groups,



current national and international medical device registries,



the Royal College of Surgeons, the Royal College of Physicians,



the Nursing and Midwifery Council,



the Medicines and Healthcare Products Regulatory Agency,



the National Institute for Health and Care Excellence,



NHS England and NHS Improvement,



such other regulatory bodies as shall have a regulatory role,



manufacturers, suppliers, commissioners, and health care providers and


their representative bodies,



academic experts in designing and analysing register data, and


Notices of Amendments: 9 March 2020                     



Medicines and Medical Devices Bill , continued



NHSX and NHS Digital.



The Secretary of State shall create such posts or bodies as needed to ensure the


creation and maintenance of the registry, and to ensure it delivers on its





The Secretary of State shall establish by regulations a mechanism ensuring that


the registry is accountable and delivers on its objectives, and to enable


transparency and access to the data in the registry by health care providers and


Clinical Commissioning Groups and such other national and international bodies


as the Secretary of State shall authorise.


Member’s explanatory statement


This new clause requires the Government to create a national registry of implanted and inserted


medical devices which tracks their history and the patient experience to improve patient safety,


enable efficient recall if needed and to evaluate device performance.



Order of the House [2 March 2020]


That the following provisions shall apply to the Medicines and Medical Devices Bill:





The Bill shall be committed to a Public Bill Committee.


Proceedings in Public Bill Committee



Proceedings in the Public Bill Committee shall (so far as not previously


concluded) be brought to a conclusion on Thursday 23 April 2020.



The Public Bill Committee shall have leave to sit twice on the first day on


which it meets.



Proceedings on Consideration and any proceedings in legislative grand


committee shall (so far as not previously concluded) be brought to a


conclusion one hour before the moment of interruption on the day on which


proceedings on Consideration are commenced.



Proceedings on Third Reading shall (so far as not previously concluded) be


brought to a conclusion at the moment of interruption on that day.



Standing Order No. 83B (Programming committees) shall not apply to


proceedings on Consideration and up to and including Third Reading.


Other proceedings



Any other proceedings on the Bill may be programmed.




Revised 10 March 2020