Knowledge Hub Article
21st May, 2018
by Bruce Lovell
Furniture and the Medical Devices Directive (MDD) 93/42/EEC - Guidance and CE marking requirements.
At a glance:
The Medical Devices Directive (MDD) has an extremely broad remit, and covers all products/equipment intended by the manufacturer to be used to diagnose, prevent, monitor, treat, alleviate, compensate for and/or control a disease, injury, handicap, physiological process or conception. It is important to understand that the intended purpose and the way a product is marketed can cause them to be covered or excluded from this directive.
Where other directives look at eliminating or reducing risk of injury the MDD takes a different view, balancing risk against benefit. Effectively the MDD accepts that some products might pose a health risk to the user, but it is outweighed by the benefits.
- How to classify your products based on their intended usage
- Guidance on what all products must be subject to (regardless of their classification)
- Understand what ‘technical information’ you need to state with the product
- Explanations of ‘EC Declaration of Conformity’ and ‘CE Marking’
- See what standards are associated with these products
The Medical Devices Directive (MDD) has an extremely broad remit, and covers all products/equipment intended by the manufacturer to be used to diagnose, prevent, monitor, treat, alleviate, compensate for and/or control a disease, injury, handicap, physiological process or conception. It is important to understand that the intended purpose and the way a product is marketed can cause them to be covered or excluded by this directive. Effectively this means that if a product is marketed (and this would include the way a sales person promotes a product) with health benefits it would be classed as a medical device.
Whilst this does not widely apply to furniture, if a rise and recline chair is promoted as helping to reduce the effects of arthritis, for example, it would be classed as a medical device, however if no mention of this is made the product would not be classed as medical device. The MDD is different from other Directives (General Product safety, Machinery, Low Voltage etc). Where other directives look at eliminating or reducing risk of injury the MDD takes a different view, balancing risk against benefit. Effectively the MDD accepts that some products might pose a health risk to the user, but it is outweighed by the benefits.
The best hypothetical examples is that if a mattress was developed that cured cancer, but failed to meet the UK's Flammability Regulations, then the mattress would be allowed as a medical device as the benefits (number of people cured) would outweigh the risk of a house fire. This leads to another important fact, that in terms of hierarchy the MDD is above all other directives. That is if a product is classed as a medical device it does not necessarily have to meet the requirements of any other EU directive (and in some cases is in conflict with them), or member state law (although it is preferably to try to and meet as many requirements as possible). It should be noted that the electrical safety requirements for medical devices are different to those contained within the Low Voltage Directive, as it is essential that the systems do not interfere with other sensitive medical equipment.
If a product is registered as a medical device in any EU member state it should be possible to sell that product as a medical device across Europe, even though standards may differ in different countries. In the UK the MDD is administered by the Medicines and Healthcare products Regulatory Authority (MHRA).
How to comply
Once the intended use has been determined, and it is decided that the product is a medical device, the next step is to define the classification of the product. Dependant on the classification a manufacturer may be able to self certify a product, or be required to have that product assessed by a Notified Body. There are four classification levels, Class I, Class IIa, IIb and III, with Class III covering the highest risk products.
- Class I - generally regarded as low risk
- Class IIa - generally regarded as medium risk
- Class IIb - generally regarded as medium risk
- Class III - generally regarded as high risk
The classification of a product will be based on:
- how long the device is intended to be in continuous use
- whether or not the device is invasive or surgically invasive,
- whether the device is implantable or active
- whether or not the device contains a substance, which in its own right is considered to be a medicinal substance and has action ancillary to that of the device.
In general furniture products fail into the Class I category. This allows self certification of a product. The MHRA publishes a valuable guide offering advice to manufacturers of Class I products on compliance with the Directive. This can be found on the MHRA website.
Basically the requirements state that a product needs to have a certain level of technical information, including:
- DESCRIPTION. A general description of the product, including any variants (for example names, model numbers and sizes).
- RAW MATERIALS AND COMPONENT DOCUMENTATION. Specifications including, as applicable details of raw materials, drawings of components and/or master patterns and any quality control procedures.
- INTERMEDIATE PRODUCT AND SUB-ASSEMBLY DOCUMENTATION. Specifications, including appropriate drawings and/or master patterns, circuits, and formulation specification; relevant manufacturing methods; and any quality control procedures.
- FINAL PRODUCT DOCUMENTATION. Specifications, including appropriate drawings, and/or master patterns, circuits, and formulation specification; relevant manufacturing methods; and any 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. The results of risk analysis to review whether any risk associated with the use of the product are compatible with high level of protection of health and safety and are acceptable when weighed against the benefits to the patient or user. If biocompatibility is relevant, for example for skin contact and invasive devices, a compilation and review of existing data or test reports based on the relevant standards is required.
- COMPLIANCE WITH THE ESSENTIAL REQUIREMENTS AND HARMONISED STANDARDS. A list of relevant harmonised standards (for example sterilisation, labelling and information, biocompatibility, electrical safety, risk analysis, product group standards) which have been applied in full or in part of the products. If relevant harmonised standards have not been applied in full, then additional data will be required detailing the solutions adopted to meet the relevant essential requirements of the Directive.
United Kingdom manufacturers of Class I devices must inform the MHRA of the address of their registered place of business and provide a description of the devices concerned, such as the categories of devices and not the description of each model. Manufacturers of Class I devices outside of the Community must designate a representative within the Community. If this representative is established within the United Kingdom, they must inform the MHRA of the address of their registered place of business, along with the description of the devices concerned. There is a fee, currently £70.00 per registration or change of registration. The regulations require this fee to accompany the technical information when it is sent to the Medicines & Healthcare products Regulatory Agency.
Once the MHRA have registered the product, the product can be CE marked and sold as a medical device.
The following standards are useful when carrying out a risk assessment:
- BS EN ISO 14971:2009 Medical devices. Application of risk management to medical devices
- BS EN 12182:1999 Technical aids for disabled persons. General requirements and test methods
For further information:
Contact: Technical Services