The most frequent borderline for products is that between medical devices and medicinal products.
In general, if a product acts pharmacologically, immunologically or metabolically it is unlikely to be considered to be a medical device. In order to determine whether a product is a device or a medicine, the definitions of both need to be considered, along with the claims for the product, the mode of action on the human body and intended purpose of the product.
The European Commission has published a guidance document (MEDDEV 2.1/3 - external link) on the borderline between medical devices and medicinal products. This provides explanations of how the determination of a borderline product should be undertaken and gives examples of various products and the correct regulatory routes.
'The MHRA has also published a guidance document 'Borderlines between medical devices and medicinal products' (163Kb), which lists various products and whether they are considered medical devices or medicinal products.
There may also be additional guidance on specific products contained in the Medical Device Expert Group’s ‘Manual on borderline and classification in the Community Regulatory framework for medical devices’.
› Manual on borderline and classification in the Community Regulatory framework for medical devices (external link)
Agents/Solutions for the transport, nutrition and storage of organs intended for transplantation
Historically, solutions for the transport, nutrition and storage of organs for transplantation were not regarded as medical devices in the UK. MEDDEV 2.1/3 (2001 version) (external link) shows that although regulation as medicinal products was considered to be the most appropriate regulatory route at the time the guidance was drafted, many EU Member States do not regulate these products as medicines, as was the case in the UK.
In 2008 the Medical Device Expert Group’s classification and borderline working group came to a consensus determination on the regulation of IVF media and following on from this, extended discussions to the regulation of solutions for the storage and preservation of organs for transplant.
In December 2008 the group agreed that these products would be considered as medical devices by analogy of the previous decision on IVF media and this consensus decision was published in the ‘Manual on borderline and classification in the Community Regulatory framework for medical devices’, a copy of which may be obtained from the European Commission’s website (external link).
In essence this consensus agreement indicates that in general agents for transport, nutrition and storage of organs, intended for transplantation can be considered to be medical devices.
MHRA will therefore accept the CE marking of these products as medical devices in future.
Manufacturers will be given time to comply with the requirements of the medical device regulations for any products they may have which meet the criteria stated in the manual of decisions. Until 31 May 2010, manufacturers may continue to place their products in the market without the CE Mark on the basis that they will be going through the CE marking process.
Manufacturers should contact their Notified Body with regard to CE marking the relevant products as soon as possible. After 31 May 2010 all such products placed on the market in the UK should be CE marked under the medical device regulations.
Note that MEDDEV 2.1/3 (external link) is currently under revision and the section referring to these products will be removed in the updated version.
Antiseptic/Disinfectant wipes and swabs
The MHRA conducted a regulatory review in 2008 with respect to the regulatory route for disinfectant/antiseptic wipes intended for use on human skin for a medical purpose and looked at those containing only alcohol and those containing antimicrobial substances such as chlorhexidine, cetrimide and iodine. As a result of this review, the MHRA published information pertaining to the acceptability of alcohol-only wipes as medical devices in July 2008. The information published on our website in July 2008 is repeated below:
Medicated and alcohol-based wipes and swabs
Medicated swabs/wipes intended for a medical purpose on humans (for example pre-injection swabs, wound cleansers or for use in a first aid kit) have historically been regulated as medicinal products. Some contain either antiseptics such as chlorhexidine, cetrimide or iodine, but others are alcohol based with no other active ingredient.
The MHRA has undertaken a comprehensive review of these types of products in the light of a number of queries regarding their regulatory status and differing views on the appropriate regulatory route within the EU. As a result of this review, the MHRA has determined that wipes/swabs containing antiseptics/antimicrobials such as chlorhexidine, iodine, cetrimide and similar will remain as medicinal products and therefore will continue to require a marketing authorisation, alcohol wipes (ie those containing alcohols and water but no other ingredients), however, have a non-specific action. The MHRA has determined that there is no reason why such alcohol wipes might not be regulated as medical devices. As a result of this determination, the MHRA will accept the placing on the market of alcohol based swabs/wipes as medical devices. Such products will therefore require to be CE marked under the Medical Device Regulations.
Products placed on the market specifically for use only on unbroken skin would be likely to be considered as Class I devices, while those for use on injured/broken skin would be likely to be regarded as Class IIa devices. It should be noted, however, that the MHRA's position on the regulation of alcohol wipes may be revised in the event of a European consensus being reached on the regulation of these products.
The publication of this advice appears to have caused a certain amount of confusion among manufacturers and healthcare professionals. There appears to be a general misunderstanding that the MHRA has changed their view on products that have ‘always been medical devices’ – this was never the case. In the UK swabs and wipes intended to be used for a medical purpose eg wound cleaning, pre/post injection were, until 2008, always regarded as medicinal products. The change in the MHRA’s view was to accept alcohol-only wipes as medical devices.
There has also been some confusion with regard to the use of the word antiseptic.
Using the word antiseptic does not necessarily make a product a medicinal product or a medical device. The word antiseptic is not considered to be a medical or medicinal claim in itself. This is because it can also be used to describe products not having a medical purpose. The key in determining which set of regulations may apply to a product making antiseptic claims will be the intended purpose for the product. Where antiseptic or disinfectant claims are made in conjunction with a medical purpose then the product is likely to come within the MHRA’s remit. Products without a stated or implied medical purpose would not.
Wipes for general purposes
Where products have disinfectant or antiseptic properties but are clearly not intended for a medical purpose, (eg hard surface disinfectants), they are likely to come within the remit of the regulations covering biocides. Manufacturers should be careful when claiming that such wipes are antiseptic as this could be considered to be misleading to the consumer. Advice should be sought from the Trading Standards Service (that administers the Fair Trading Regulations) or the Health and Safety Executive (that administers the Biocides regulations).
Wipes for use on medical devices
Only products that are specifically intended for the disinfection of medical devices are considered to be medical devices and may be CE marked under the medical device regulations. Products that are intended to be used as multi-purpose hard surface disinfectants/cleansers and/or general environmental disinfectants are not considered to come within the remit of the medical device regulations. There is no provision under the medical device regulations for disinfectants labelled primarily for use with medical devices with subsidiary claims for multi-purpose use, therefore such products should be marketed separately under the different sets of legislation.
Wipes for use on human skin
Wipes that are intended to be used for a medical purpose, eg pre/post injection, wound cleaning etc, that contain antimicrobial substances are regarded to be medicinal products: Wipes for these uses containing alcohol only will now be accepted as medical devices in the UK until a European consensus has been reached on the regulation of these products.
Therefore all such products must have either a marketing authorisation under the medicines regulations or be CE marked under the medical device regulations. Wipes that are intended as general cleansers (eg for hands) with no specific medical purpose are unlikely to come within the MHRA’s remit unless medicinal claims were made. Their intended purpose must be made clear to ensure that the intended purpose cannot be misconstrued eg marked as ‘hand cleansing wipes’ and clearly indicated as not for use on injured skin and wounds. Such products are likely to come within the regulations on biocides.
Wipes for use in first aid kits
Where antiseptic wipes are intended to be placed in first aid kits their specific intended purpose must be clear. If they are intended to be for cleaning a wound or for use on injured skin then they will be either medicinal products or medical devices (depending on whether or not they are alcohol only) and should therefore either have a marketing authorisation or be CE marked. If they are intended only as a hand cleansing wipe for use prior to treating a wound then this must be clearly stated on the packaging – eg labelled ‘hand cleansing wipes’ – and be clearly indicated as not for use on injured skin/wounds. Such hand cleansing wipes are likely to be either biocides or cosmetic products.
Where a manufacturer is unsure of the correct regulatory route for a product, further advice may be sought from the MHRA.
Contact: MHRA (Devices), European Regulatory Affairs
Tel: 020 3080 7386/7185
Contact: MHRA (Medicines)
Tel: 020 3080 6467/6076