Medical Devices (1st January 2021 onwards)

The UK left the EU on 31 January 2020 and existing EU medical device legislation has continued to apply in the UK under the terms of the EU-UK Withdrawal Agreement during the Brexit transition period. When that period expires on 31 December 2020, existing EU legislation will be automatically incorporated into UK domestic legislation in so far as possible. Meanwhile, the Medical Device Regulations (MDR) and In Vitro Diagnostic Medical Devices Regulations (IVDR) will fully apply in EU Member States from 26 May 2021 and 26 May 2022 respectively. These regulations will not take effect until after the transition period with the EU has ended. Consequently, the new devices regulations will not be retained automatically in UK law and shall not be applicable in Great Britain – this point has been confirmed by the MHRA (1st September 2020). After 31st December 2020, the UK shall become a 3rd country and devices destined for the EU market will need to adhere to the relevant EU legislation and be affixed with the CE mark to demonstrate compliance. This will not be possible without legal presence in Europe. The position is very complex, may be subject to further change.

**Disclaimer** Device aspects and idiosyncrasies (examples: location of assembly, manner of combination products, companion diagnostics, original route to compliance ,up-classing under the new regulations etc..) all have the ability to change the regulatory pathway from those details provided below. Each client and each device in the portfolio should be treated on a case by case basis.

Example 1 – UK importer of CE marked devices (already EU legal)

–       With an EU Legal Manufacturer / Authorised Representative [EC REP]

–       With an EEA Notified Body, where applicable.

United Kingdom

Status Quo

  • CE marking will continue to be used and recognised until 30 June 2023. This is true for devices conforming to the old EU directives and the new EU regulations, until the old EU directive have been fully superseded.
  • CE certificates issued by EEA based Notified Bodies (NB’s are private companies) will continue to be valid for the GB market until 30 June 2023.
  • The MHRA will continue to perform market surveillance of medical devices on the UK market and will be able to take decisions over the marketing and supply of devices in the UK.
  • The MHRA will continue to be responsible for the designation and monitoring of UK Conformity Assessment Bodies.

 

New requirements

MHRA Registration

  • From 1 January 2021, all Devices & IVD’s placed on the UK market must now be registered with the MHRA (Statutory fee £100). Grace periods apply.
    • 4 months for Class IIIs and Class IIb implantables, and all active implantable medical devices
    • 8 months for other Class IIb and all Class IIa devices
    • 12 months for Class I devices

NB: The above 12-month grace period will not apply to manufacturers of Class I devices and general In Vitro Devices (IVDs) that are currently required to register with the MHRA.

Responsible Person (UK RP)

  • Ex-UK manufacturers without a registered office in UK must designate a UK (resident) Responsible Person (UK RP).
  • The UK RP role can be fulfilled by an individual or corporate entity.
  • The UK RP will act on behalf of the manufacturer to fulfil the manufacturers obligations in the UK. Obligations are laid out in the UK MDR 2002 (in the form in which they exist on 1 January 2021). The grace periods for registration are also applicable for UK RP
  • The UK RP may also be the importer (the importer has legal obligations in any case).

UK RP role is summarised below:

Note that there are no educational or experiential prerequisites for UK RP’s who will oversee and be responsible for the UK based activities for ‘already’ EU legal devices.

  • Registering new devices (after 1st January 2021) with the MHRA before the manufacturer’s devices can be placed on the UK market. Ensuring grace periods are noted (as above).
  • Bona fides checks – Need basic devices regulatory knowledge to ensure that:
    • The Declaration of Conformity (DoC) has been drawn up and is legal
    • The technical documentation has been drawn up correctly
    • Where applicable, an appropriate conformity assessment procedure has been carried out by the manufacturer.
  • Have immediate access to (not necessarily hold) the following docs for MHRA inspection
    • A copy of the technical documentation (all that support devices compliance)
    • The Declaration of Conformity (DoC)
    • Any relevant certificates, amendments, supplements
  • Provide MHRA with any relevant information, immediately at the point of request
  • Act as interface for MHRA sample requests and ensure authority satisfaction
  • Cooperate with MHRA on CAPA and any MHRA imposed actions/local sanctions
  • Maintain complaints register and immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.
  • Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations and inform the MHRA and, if applicable, the relevant notified body of that termination.

UKCA Mark

From 1st July 2023, all devices placed on the Great Britain market must meet UKCA mark requirements and be labelled accordingly.

    • This requirement will not apply to Northern Ireland traders.
    • Devices may be dual-labelled in the UK (CE mark and UKCA) after July 2023.
    • UKCA mark will not be recognised in the EU, EEA or Northern Ireland markets.
    • New devices must meet UKCA requirements from 1st January 2021.

Labelling

  • As of 1 January 2021, medical devices placed on the GB market will need to have either a UKCA mark or a CE mark, depending on which legislation the device has been certified under.
  • Where relevant, the number of the Notified Body or UK Approved Body will also need to appear on the label.
  • If you already have a valid CE mark on your device, you will not be required to re-label the device with a UKCA mark until 1 July 2023.
  • Devices that are dual labelled with both the CE and UKCA marks will continue to be accepted on the Great Britain market after 1 July 2023.

Changes

Notified Bodies (NB)

NB’s are required to assess conformity and place their number on the device for the following risk classes:

    • Class Is (sterile)
    • Class Im (measuring)
    • Class Ir (reusable (surgically)) – This is a new class under MDR
    • Class IIa
    • Class IIb
    • Class III

There are only two NB’s currently left in UK (for devices), and only one of which is designated against MDR.

      • BSI Healthcare (0086) Designation: MDD, AIMD, IVDD, MDR
      • SGS United Kingdom Ltd (0120) Designation: MDD, IVDD
  • From 1st January 2021, UK Notified Bodies shall no longer be recognised in the EU.
  • Certificates issued by European Economic Area (EEA)-based Notified Bodies will continue to be valid for the Great Britain market until 30th June 2023
  • After 1st January 2021, UK Notified Bodies shall be recognised as ‘UK Approved Bodies’.
  • From 1st January 2021, the MHRA will be able to designate UK Approved Bodies to conduct assessments against the relevant requirements for the purpose of the UKCA mark.
  • The 2 bodies named above (BSI & SGS) shall have their designation under the MDD and IVDD (the old directives) rolled over automatically without having to undergo a new designation process.
  • UK Approved Bodies will only be able to conduct conformity assessments, in relation to the UKCA mark, for medical devices, active implantable medical devices and in vitro diagnostic medical devices under Parts II, III, and IV of the UK MDR 2002 (in the form in which they exist on 1st January 2021)

Example 2 – Northern Ireland (General implications)

  • From 1st January 2021, the regulation of medical devices in Northern Ireland will fall under the terms of the Northern Ireland Protocol.
  • The rules for placing medical devices on the Northern Ireland market will differ from those applicable to Great Britain.
  • Unlike the rest of GB, The Medical Device Regulations (2017/745) and the in vitro Diagnostic Medical Device Regulations (2017/746) will apply in Northern Ireland from 26th May 2021, and 26th May 2022 respectively, in line with the EU’s implementation timeline.
  • Northern Ireland-based manufacturers already registered with the MHRA for the purposes of Northern Ireland may allow devices to freely flow between Northern Ireland and Great Britain without any further registration in Great Britain.
  • Devices that have been CE marked by Northern Ireland traders will continue to be accepted on the Great Britain market beyond 30th June 2023. This will apply to devices that have been self-certified or have undergone mandatory third-party conformity assessment by an EEA-based Notified Body.
  • From 1st July 2023, to place a device on the Great Britain market, you will need to meet the requirements for placing a UKCA mark on your device. This requirement will not apply to Northern Ireland traders.
  • Where a device has been assessed by a UK Approved Body, the UK(NI) mark will accompany, but not replace, the CE mark. Products carrying both the CE mark and UK(NI) mark cannot be placed on the EU market.
  • UKCA marked devices will not be accepted on the Northern Ireland market unless accompanied by the CE or CE UK(NI) mark.
  • UK RP requirement also will apply for Northern Ireland from 1st January 2021 but they are complex and the requirements depends on the location of the legal entities (All outcomes are not included here but may be easily derived).
  • The MHRA will continue to be the Competent Authority for post-market surveillance activity for devices placed on the Northern Ireland market. Where incidents occur in Northern Ireland, these will need to be reported to the MHRA.

Example 3 – Authorised Representatives (AR)

The client is an UK AR or uses the services of an UK AR .

Status quo

  • If a manufacturer does not have a physical location in Europe, they are required to appoint an Authorized Representative (also referred to as an EC REP or AR) to place their devices on the EU market.

An AR means any natural or legal person established within the EU who has received and accepted a written mandate from a manufacturer located outside the EU, to act on their behalf in relation to specified tasks and obligations under the devices regulations.

  • An Importer may also be the AR.
  • If an AR is established but is not the importer, the importer still has legal obligations which are similar but less onerous.

 

Regulatory changes

  • Clients with GB-based AR’s or who are GB based AR’s will not be able to place devices on the EU market from 01 January 2021, regardless of when products were placed on the market.

They will need to establish an AR based in the EU or Northern Ireland, ASAP.

  • From 01 January 2021, Devices placed on the Northern Ireland market will need to meet EU labelling requirements, but will need to be affixed with a CE (UK/NI) mark if any mandatory conformity assessment has been undertaken by a UK Approved Body.

Example 4 – UK legal manufacturer exporting to EU

Status quo

  • From 1 January 2021, devices destined for the EU market will need to adhere to the relevant EU legislation and be affixed with the CE mark to demonstrate compliance.

New requirements

Must now have the services of an EU, EEA or NI based NB

  • From 01st January 2021, UK Notified Bodies will no longer be recognised in the EU

Where required, the UK manufacturer must now appoint an EU, EEA or Northern Ireland based Authorised Representative (no grace period).

That EU AR shall be responsible for registering the device with their own CA and will take responsibility for the device in the EU.

  • Where UK-based Legal Manufacturers used a UK-based Notified Body to conduct the mandatory third-party conformity assessment, the following will apply:
    • If your device is placed on the EU market before 1st January 2021, in accordance with the terms of the Withdrawal Agreement, it may remain on the EU market (i.e. No recall or removal of that product)
    • From 1st January 2021, you will not be able to place a device on the EU market if your mandatory third-party conformity assessment has been conducted by a UK Notified Body.

Class I self-certifying manufacturers located in UK

  • Class I self-certified devices may continue to be placed on the EU market after 1st January 2021 but UK LM will now need to appoint an EU or Northern Ireland-based Authorised Representative.
Matt Burton