EXPLANATORY MEMORANDUM TO THE MEDICAL DEVICES (AMENDMENT) (EU EXIT) REGULATIONS 2021
2021 No. [XXXX]
1. Introduction
1.1 This Explanatory Memorandum has been prepared by the Department of Health and
Social Care and is laid before Parliament by Act.
1.2 This memorandum contains information for the Sifting Committees.
2. Purpose of the instrument
2.1 This instrument is required to ensure that the United Kingdom (‘UK’) has a
functioning statute book following the end of the Implementation Period (IP) and to
ensure that essential EU tertiary legislation can operate effectively within the UK
regulatory system.
2.2 This instrument amends The Medical Devices Regulations 2002 (as they apply in
Great Britain) in accordance with Schedule 1 of this instrument.
2.3 The following EU tertiary legislation concerning medical devices is amended in
accordance with Schedule 2 of this instrument:
(i) Commission Decision 2002/364/EC of 7th May 2002 on common technical
specifications for in vitro-diagnostic medical devices;
(ii) Commission Regulation (EU) No 207/2012 of 9th March 2012 on electronic
instructions for use of medical devices;
(iii) Commission Regulation (EU) No 722/2012 of 8th August 2012 concerning
particular requirements as regards the requirements laid down in Council
Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical
devices and medical devices manufactured utilising tissues of animal origin;
(iv) Commission Implementing Regulation (EU) No 920/2013 of 24th September
2013 on the designation and supervision of notified bodies under Council
Directive 90/385/EEC on active implantable medical devices and Council
Directive 93/42 on medical devices.
2.4 These amendments are being made to ensure that the regulatory landscape for medical
devices is fit for purpose following the end of the IP. They will address failures of
retained EU Law to operate effectively and correct other deficiencies.
Explanations
What did any relevant EU law do before IP completion day?
2.5 EU law provides for a harmonised EU regulatory system for medical devices – of
which the UK was a part of until 31 December 2020. This includes the system of
conformity assessment, which is required for all medical devices placed on the EU
market. The EU regime consisted of Directive 90/385/EC on active implantable
medical devices, Directive 93/42/EC on general medical devices and Directive
98/79/EC on in vitro Diagnostic Medical Devices, which were implemented into UK
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law by the Medical Devices Regulations 2002 (“the 2002 Regulations”) and several
pieces of directly applicable EU tertiary legislation.
2.6 This EU tertiary legislation deals with matters relating to: the common specifications
for certain types of in vitro diagnostic medical devices such as testing kits for HIV;
the circumstances in which electronic instructions for use of medical devices could be
given; the regulatory requirements for medical devices which contain tissues of
animal origin; and the detailed requirements for conformity assessment bodies to
apply to become EU notified bodies.
2.7 From 1 January 2021 the Medicines and Healthcare products Regulatory Agency
(MHRA) took on the responsibilities for regulating medical devices on the UK market
to ensure the continued safety of patients. Changes are now required to ensure that the
UK statute book reflects the correct policy positions following the end of the IP.
What will these regulations do?
2.8 Schedule 1 makes amendments to the 2002 Regulations (as they apply in Great
Britain) to correct a number of deficiencies which were not made when those
Regulations were amended by the Medical Devices (Amendment etc.) (EU Exit)
Regulations 2020 S.I. 2020/1478.
2.9 This Schedule makes a number of technical amendments to the 2002 Regulations,
corrects some errors and makes a number of textual amendments. In particular, textual
amendments are made to references to EU legislation or EU bodies so that those
references are to domestic legislation or to domestic UK based bodies. For example,
the following terms have been changed from (EU) ‘Notified Bodies’ to (UK)
‘Approved Bodies’ and references to (EU) ‘harmonised standards’ to (GB)
‘designated standards’. The Schedule also makes provision for manufacturers of small
medical devices to be able put a small sized UKCA mark on their devices.
2.10 Schedule 2 makes amendments to a number of pieces of EU tertiary legislation,
retained under the EU Withdrawal Act 2018, which relate to medical devices; to
ensure that this tertiary legislation operates effectively in the context of UK medical
devices regulation (as it applies in Great Britain).
2.11 In particular, Schedule 2 makes amendments to four pieces of EU tertiary legislation
(listed above in paragraph 2.3) to remove processes and procedures which are not
relevant to the operation of that legislation in a domestic context and makes textual
amendments to references to EU legislation or EU bodies so that those are references
to domestic legislation or to domestic UK based bodies.
3. Matters of special interest to Parliament
Matters of special interest to the Sifting Committees
3.1 This instrument is being laid for sifting by the Sifting Committees.
Matters relevant to Standing Orders Nos. 83P and 83T of the Standing Orders of the House
of Commons relating to Public Business (English Votes for English Laws)
3.2 As the instrument is subject to negative resolution procedure there are no matters
relevant to Standing Orders Nos. 83P and 83T of the Standing Orders of the House of
Commons relating to Public Business at this stage.
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4. Extent and Territorial Application
4.1 The territorial extent of this instrument is the United Kingdom.
4.2 The territorial application of this instrument is England, Wales and Scotland.
5. European Convention on Human Rights
5.1 The Minister of State for Health, Edward Argar, has made the following statement
regarding Human Rights:
“In my view the provisions of The Medical Devices (Amendment) (EU Exit)
Regulations 2021 are compatible with the Convention rights.”
6. Legislative Context
6.1 Currently, devices are regulated under the 2002 Regulations. In addition, there are
various pieces of EU tertiary legislation which supplement the framework.
6.2 The 2002 Regulations and the EU tertiary legislation therefore represent the ‘retained
EU law” on medical devices under sections 2 and 3 (respectively) of the European
Union (Withdrawal) Act 2018 (EUWA).
6.3 The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (SI 2020 No.
1478) substantially amended the 2002 Regulations to reflect the position at the end of
2020 under the Northern Ireland Protocol and also made amendments to the Medical
Devices (Amendment etc.) (EU Exit) Regulations 2019 S.I. 2019/791 which in turn
made amendments which applied only to Great Britain. Taken together these
amendments reflected the different legal arrangements in Great Britain and Northern
Ireland.
6.4 Section 8 EUWA provides that a Minister of the Crown may by regulations make such
provision as the Minister considers appropriate to prevent, remedy or mitigate (a) any
failure of retained EU law to operate effectively; or (b) any other deficiency in
retained EU law arising from the withdrawal of the UK from the EU.
6.5 The EU Withdrawal Agreement Act 2020 made amendments to EUWA to take
account of the IP and to provide for the implementation of the Withdrawal
Agreement.
6.6 These Regulations exercise the powers in section 8 of EUWA to amend the 2002
Regulations to ensure that aspects of UK law in relation to medical devices operate
effectively, comply with the relevant agreements and are not deficient.
7. Policy background
What is being done and why?
Making corrections to the UK statute book
7.1 This instrument corrects deficiencies in UK legislation resulting from the UK’s
withdrawal from the EU. These changes are being made to ensure that the UK has an
accurate, fully functioning regulatory framework for medical devices.
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Updating terminology and providing clarity.
7.2 Schedule 1 of this Instrument amends the 2002 Regulations to provide clarity on
issues relating to the terminology used in this legislation so that it reflects the UK
regulatory structure.
7.3 For example, Schedule 1 substitutes references to (EU) “Notified Bodies” with
references to (UK) “Approved Bodies” and references to (EU) “harmonised
standards” to (GB) “designated standards”.
7.4 The Schedule also makes a technical amendment to ensure that small medical devices
are correctly marked
Clarifying size requirements for the UKCA marking
7.5 Schedule 1 of this instrument amends the Medical Device Regulations 2002 to provide
that minimum sizing requirements for the UKCA marking will not apply, where,
having regard to the small size of the device, it is not possible for the device to bear a
marking of that minimum size provided that the UKCA marking continues to meet
relevant requirements as to visibility, legibility and indelibility..
Amending references to EU institution and process in relevant EU tertiary legislation
7.6 Schedule 2 of this instrument amends EU tertiary legislation concerning medical
devices to change references and terminology used so that it reflects the structures and
processes in domestic regulatory structures. In addition, references to “designating
authorities” (EU bodies) are replaced with references to the Secretary of State.
7.7 The amendments to legislation remove the need for consultation and involvement of
the EU Commission and Member States in the assessment of active implantable
medical devices and medical devices manufactured utilising tissues of animal origin
(TSE susceptible material) as well as the assessment during the designation of UK
Approved Bodies.
7.8 Examples of the changes include references to “Notified Bodies” (EU term) amended
to “Approved Bodies” (GB term), references to CE marking (EU term) amended to
refer to the UKCA marking (GB term) and references to UK Responsible Persons are
added.
8. European Union (Withdrawal) Act/Withdrawal of the United Kingdom from the
European Union
8.1 This instrument is made using the powers in section 8 of the European Union
Withdrawal Act 2018 (c. 16) in order to address failures of retained EU Law to
operate effectively and to correct other deficiencies. Schedule 1 makes amendments to
the 2002 Regulations (as they apply in Great Britain) to correct a number of
deficiencies. Schedule 2 makes amendments to several pieces of EU tertiary
legislation which relate to medical devices to ensure that legislation operates
effectively in the context of the 2002 Regulations (as they apply in Great Britain).
8.2 In accordance with the requirements of EUWA the Minister has made the relevant
statements as detailed in Part 2 of the Annex to this Explanatory Memorandum.
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9. Consolidation
9.1 There are no plans to consolidate the legislation amended by this instrument.
10. Consultation Outcome
10.1 No formal consultation took place. An informal consultation conducted by the MHRA
took place on The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.
10.2 The devolved administrations have been engaged on these changes.
11. Guidance
11.1 Post-Implementation Period guidance for medical devices is available at:.
https://www.gov.uk/government/collections/new-guidance-and-information-forindustry-from-the-mhra#devices
12. Impact
12.1 An impact assessment has not been produced for this instrument as no, or no
significant, impact on private, public or voluntary sectors is foreseen.
13. Regulating small business
13.1 The legislation applies to activities that are undertaken by small businesses.
13.2 The MHRA will seek to minimise the legislation’s impact by providing guidance to
relevant stakeholders.
13.3 The basis for the final decision on what action to take to assist small businesses is to
maintain patient safety whilst supporting the continued safe supply of medical devices
to the UK market.
14. Monitoring & review
14.1 As this instrument is made under the EU Withdrawal Act 2018, no review clause is
required.
15. Contact
15.1 Jason Eldridge at the Medicines and Heath products Regulatory Agency email:
Jason.Eldridge@mhra.gov.uk can be contacted with any queries regarding the
instrument.
15.2 Jack Turner at the Medicines and Health products Regulatory Agency can confirm
that this Explanatory Memorandum meets the required standard.
15.3 The Minister of State for Health, Edward Argar, at the Department of Health and
Social Care can confirm that this Explanatory Memorandum meets the required
standard.
