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Guidance on Class I medical devices

Advice for manufacturers of Class I medical devices for selling products in the UK

Overview

This guidance applies to manufacturers of Class I medical devices, including accessories but excluding devices intended for clinical investigation and custom-made devices.

This guidance is divided into sections on the different rules that apply in Great Britain (England, Wales and Scotland) and Northern Ireland.

For Northern Ireland, different rules apply to those in Great Britain. For more information on the regulatory system for medical devices in Northern Ireland, please see the section on Class I devices in Northern Ireland below.

CE marked devices will continue to be accepted on the Great Britain market until 30 June 2023. You will be able to self-certify your Class I medical device for the CE mark, and place your device on the Great Britain market. You will not require an Authorised Representative if you are solely placing your Class I device on the Great Britain market. If you are self-certifying your Class I medical device for the CE mark, you will need to meet the requirements of the Medical Devices Regulation (2017/745) from 26 May 2021. See our guidance for more information on the use of the CE mark for Great Britain.

How to check the product is a medical device

If you are a manufacturer or UK Responsible Person placing medical devices on the Great Britain (England, Wales and Scotland) market you should refer to the following to confirm that your products fall within the definition of a medical device:

Summary of the requirements for Manufacturers of Class I devices

UKCA mark requirements for medical devices are based on the requirements of the relevant Annexes to the European Directive 93/42/EEC on medical devices (EU MDD) as modified by Part II of Schedule 2A of the UK Medical Device Regulations 2002 as they apply in Great Britain. To self-certify your Class I medical device for the UKCA mark you need to:

  • confirm that your products are Class I medical devices as described in Part II of the UK MDR 2002, Annex IX (as modified by Part II of Schedule 2A to the UK MDR 2002)
  • check that your products meet the relevant essential requirements of Part II of the UK MDR 2002, Annex I (as modified by Part II of Schedule 2A to the UK MDR 2002)
  • carry out a clinical evaluation as described in Part II of the UK MDR 2002, Annex X (as modified by Part II of Schedule 2A to the UK MDR 2002)
  • notify the MHRA of any proposals to carry out a clinical investigation to demonstrate safety and performance
  • prepare technical documentation
  • if your medical device is sterile or has a measuring function, get approval from a UK Approved Body
  • draw up the declaration of conformity
  • put the UKCA mark on your devices as described in Regulation 85 of the UK MDR 2002
  • register with the MHRA
  • implement and maintain corrective action and vigilance procedures including a systematic procedure to review experience gained in the post-production phase
  • provide relevant documentation if requested by the MHRA

UKCA mark

A UKCA mark is a logo that is placed on medical devices by a manufacturer in order to indicate that their product conforms to the requirements of the UK MDR 2002. It indicates that the device works in accordance with the intended purpose and meets legislation relating to safety and performance.

You must sign a ‘declaration of conformity’ before you can place the UKCA mark on your product. Further information on this procedure.

For sterile and measuring devices, the UKCA mark must also have the identification number of the Approved Body that approved this part of the conformity assessment.

More information on how to apply the UKCA mark.

Technical documentation

You must keep technical documentation that demonstrates that your products conform to the requirements of the UK MDR 2002. You must have this documentation prepared before drawing up the declaration of conformity. You must keep the documentation for a period ending at least 5 years after the last products have been manufactured. The MHRA can ask to see the documentation at any time.

Where manufacturers are required to have a UK Responsible Person, they must ensure that the UK Responsible Person keeps available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA.

The technical documentation must cover all aspects listed below.

Description

A general description of the product, including any variants (for example names, model numbers and sizes).

Raw material and component documentation

Specifications such as:

  • details of raw materials
  • drawings of components and/or master patterns
  • quality control procedures

Intermediate product and sub-assembly documentation

Specifications including:

  • appropriate drawings and/or master patterns
  • circuits
  • formulation specification
  • relevant manufacturing methods
  • quality control procedures

Final product documentation

Specifications including:

  • appropriate drawings and/or master patterns
  • circuits
  • formulation specification
  • relevant manufacturing methods
  • quality control procedures

Packaging and labelling documentation

Packaging specifications and copies of all labels and any instructions for use.

Design verification

The results of qualifications tests and design calculations relevant to the intended use of the product, including connections to other devices in order for it to operate as intended.

Risk analysis

Looks at whether risks associated with the use of the product are compatible with high-level protection of health and safety and are acceptable when weighed against the benefits to the patient or user. For example, if biocompatibility is relevant (i.e. for invasive devices) you will need to compile and review existing data or test reports based on the relevant standards.

Compliance with essential requirements

You need to demonstrate that you meet the relevant essential requirements outlined in Part II of the UK MDR 2002, Annex I (as modified by Part II of Schedule 2A to the UK MDR 2002).

Not all the essential requirements will apply to your product so you will need to identify which requirements do apply and provide evidence to demonstrate how you meet these. One way of demonstrating that you meet specific essential requirements is by developing your product in accordance with relevant designated standards. The technical documentation needs to include a description of how each relevant essential requirement has been complied with including a list of relevant designated standards that have been applied, in full or in part, concerning the manufacture and design of the product.

Clinical evaluation in accordance with Annex X

A clinical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device is required under Part II of the UK MDR 2002, Annex X (as modified by Part II of Schedule 2A to the UK MDR 2002). The data needs to adequately demonstrate that the product fulfils its intended purpose. The intended purpose includes any claims made as part of marketing material supplementary to those made in the technical file.

Declaration of conformity

In order to put the UKCA mark on your products, you must follow the EC declaration of conformity procedure described in Part II of the UK MDR 2002, Annex VII (as modified by Part II of Schedule 2A to the UK MDR 2002). You must do this before placing the device on the market.

You must keep the documentation for a period ending at least 5 years after the last products have been manufactured. This is so the MHRA can investigate any problems with a device even if it is no longer on the market.

In addition, if you manufacturer sterile or measuring devices you must make available any other information for the particular conformity assessment procedure, such as Approved Body approval and quality system documentation.

Clinical evaluation

You must carry out a clinical evaluation for all Class I devices to demonstrate conformity with the essential requirements set out in Part II of the UK MDR 2002, Annex I (as modified by Part II of Schedule 2A to the UK MDR 2002). The evaluation involves looking at published clinical data to prove that the medical device works as intended and is safe to use.

Guidance document MEDDEV2.7/1 describes what is expected in an evaluation.

A clinical evaluation is not the same as a clinical investigation (CI). A CI may form part of a clinical evaluation. For example, if there isn’t enough pre-existing evidence to demonstrate that the device conforms with the essential requirements, a specifically designed CI may be necessary. In this case you will have to notify the MHRA in advance of doing the investigation. MEDDEV2.7/1 includes guidance on deciding whether you need to do a CI.

The clinical evaluation of the device needs to be continually reviewed after the device has been placed on the market. Your review should take into account the outcomes of any post market surveillance activities or user feedback. The technical documentation should be updated accordingly.

Extra requirements for sterile Class I devices

You will have to find a suitable Approved Body to get approval for the aspects of manufacturing concerned with securing and maintaining sterile conditions. You can only ask one Approved Body at any one time for approval of particular product ranges and they will charge a fee for their services. Names and addresses of UK Approved Bodies.

Extra requirements for Class I devices with a measuring function

Class I devices are considered to have a measuring function if they are either syringes with volume indicators or they are a device that measures a physiological parameter and display or indicate the value in a unit of measurement appropriate to the intended purpose. Examples include thermometers, eye tonometers, and lung function monitors including vital capacity meters.

Devices incorporating indicators that merely show a change in level or state without indicating a specific value, or indicate a specific value of no direct relevance to patient safety, do not exhibit a measuring function in terms of the UK MDR 2002.

Guidance document MEDDEV 2.1/5 provides additional information on devices with a measuring function.

You will need to employ a suitable Approved Body to get approval for the aspects of manufacturing concerned with the measuring requirements (for example calibration and inspection).

Post-market surveillance, corrective action and vigilance procedure

You must immediately notify the MHRA if you find out that your product has been involved in an incident that:

  • led to a death
  • led to a serious injury or serious deterioration in the health of a patient, user or other persons
  • might have led to death, serious injury or serious deterioration in health

You also must tell the MHRA of any technical or medical reason leading to the recall of a device.

You must put in place, and keep updated, a documented procedure to review experience gained from devices on the market and to implement any necessary corrective action, according to the nature and risks involved with the product. This is referred to as ‘post-market surveillance’.

Further information on post-market surveillance and vigilance.

Situations in which a Class I1 device will not be considered compliant with the UK Medical Devices Regulations 2002 include the following:

  • it is not appropriately marked
  • the medical device displays a UKCA mark but the manufacturer has not fulfilled the requirements outlined in the UK MDR 2002
  • the manufacturer is not based within the UK and does not have an UK Responsible Person
  • the manufacturer or UK Responsible Person has not registered the device with the MHRA before placing it on the market once the registration grace periods have passed
  • the clinical data provided to the MHRA does not include an evaluation of all the relevant published scientific literature and so the effectiveness of the device is exaggerated

Additional requirements

Phthalates

The use of phthalates in the design and construction of a medical device must be justified in the technical documentation. This is because phthalates can be carcinogenic, mutagenic or toxic to reproduction. Justification must take into account the risk-benefit analysis of the use of such a substance.

If the use of phthalates is justified, then the instructions for use must include information on any risks associated with using a product that contains phthalates.

Furthermore, a medical device containing phthalates must be labelled in accordance with essential requirement 7.5 of Part II of the UK MDR 2002, Annex I (as modified by Part II of Schedule 2A to the UK MDR 2002) if it is intended to:

  • administer and/or remove medicines, body fluids or other substances to or from the body
  • transport and store medicines, body fluids or other substances that will be administered
  • an example of a Class I device where phthalates could be an issue is the tubing in an administration set

Machinery

Medical devices that are also machinery should also meet relevant essential requirements of the Machinery Directive (2006/42/EEC) implemented in the UK by the Supply of Machinery (Safety) (Amendment) Regulations 2011.

Personal protective equipment (PPE)

Some medical devices share characteristics with PPE. For these products you will need to clearly indicate which legislation your product has been UKCA marked under i.e. medical devices, PPE or both. The stated, intended purpose of the device will dictate the conformity assessment you’ll have to do. Please see our guidance page on borderlines with medical devices.

Class I Devices on the Northern Ireland market

The UKCA mark is not recognised on the Northern Ireland market. Instead you will need to apply a CE mark to your device. If you have a Class I device, you can self-certify for the CE mark.

Where your Class I device has a measuring function or is sterile, and an Approved Body has been used, in addition to the CE mark, you must use the UKNI marking. Devices bearing the CE UKNI mark will not be accepted on the EU market.

Manufacturers based in Northern Ireland will not require an Authorised Representative to self-certify for the CE mark. Manufacturers based in Great Britain (England, Wales and Scotland) wishing to place a CE marked device on the Northern Ireland market will require an Authorised Representative based in Northern Ireland or the EU.

Until 25 May 2021 CE mark requirements for Class I medical devices will continue to be based on the requirements stated in the Directive 93/42/EEC on medical devices (EU MDD).

From 26 May 2021 CE mark requirements for medical devices on the Northern Ireland market will be based on the EU Medical Devices Regulations 2017/745 (the EU MDR). Further information on compliance with the EU MDR.

Published 4 October 2016
Last updated 31 December 2020 + show all updates
  1. This guidance has been updated due to the end of the Brexit transition period.

  2. First published.