Guidance on class 1 medical devices

Advice for manufacturers of class 1 medical devices for selling products in the UK

Guidance on class 1 medical devices

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

If you are a manufacturer or authorised representative placing medical devices on the EU market you should refer to the following to confirm that your products fall within the definition of a medical device:

Medical Devices Regulations 2002

• device classification rules in Annex IX of the Medical Devices Directive (MDD)

• European Commission’s guidance – MEDDEV2.1/6

MHRA guidance on Borderlines with medical devices

MHRA guidance on Medical device stand-alone software including apps

Summary of the requirements for Manufacturers of class I devices

• confirm that your products are class I medical devices as described in Annex IX of the MDD

• check that your products meet the relevant essential requirements of Annex I of the MDD

• carry out a clinical evaluation as described in Annex X of the MDD

notify 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 notified body approval

• draw up the ‘EC declaration of conformity’

• put the CE marking on your devices as described in Article 17 of the MDD

register with 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 MHRA requests it

CE marking

A CE 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 directives. It indicates that the device works in accordance with the intended purpose and meets legislation relating to safety and performance. A product that bears a CE mark can be freely marketed anywhere in the European Union.

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

For sterile and measuring devices, the CE marking must also have the identification number of the notified body that approved this part of the conformity assessment.

Technical documentation

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

The technical documentation must cover all of the aspects listed below.


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 labeling 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 annex 1 of the MDD. Not all of 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 harmonised standards. The technical documentation needs to include a description of how each relevant essential requirement has been complied with including a list of relevant harmonised 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. The data needs to adequately demonstrate that the product fulfills its intended purpose. The intended purpose includes any claims made as part of marketing material supplementary to those made in the technical file.

EC declaration of conformity

In order to put the CE marking on your products, you must follow the EC declaration of conformity procedure described in Annex VII of the MDD. 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 that 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 notified 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 of the MDD. The evaluation involves looking at published clinical data to prove that the medical device works as intended and is safe to use.

The European Commission’s guidance MEDDEV2.7/1 describes what is expected in an evaluation.

Note: 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 of the MDD, a specifically designed CI may be necessary. In this case you will have to notify MHRA in advance of doing the investigation. The European Commission’s document MEDDEV 2.7/4 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 notified body to get approval for the aspects of manufacturing concerned with securing and maintaining sterile conditions. You can only ask one notified 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 notified bodies are on this page, although you can use any notified body that has been designated to certify medical devices under the MDD in Europe.

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 MDD.

The European Commission’s guidance document MEDDEV 2.1/5 provides additional information on devices with a measuring function.

You will need to employ a suitable notified 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 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 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’. The European Commission has issued ‘Guidelines on a medical devices vigilance system’.

Situations in which a class 1 device will not be considered compliant with the UK Medical Devices Regulations 2002 include the following:

• it is not CE marked

• the medical device displays a CE mark but the manufacturer has not fulfilled the requirements outlined in the MDD

• the manufacturer is not based within the EU and does not have an authorised representative

• the manufacturer or authorised representative is not registered with the relevant EU competent authority

• the clinical data provided to MHRA does not include an evaluation of all the relevant published scientific literature and so the effectiveness of the device is exaggerated

Additional requirements


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 annex 1 of the MDD 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.


Medical devices that are also machinery should also meet relevant essential requirements of the Machinery Directive. The European Commission has produced an interpretative document on this subject.

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 CE 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. The European Commission has produced an interpretative document on this subject.

Published 4 October 2016