Device Regulators MHRA publish Guidance Notice on Borderlines With Medical Devices
Many manufacturers have difficulty in interpreting whether or not their product would be considered a medical device within the terms of the Medical Device Directive 93/42/EEC. This guidance document has been developed to aid with some of the more common areas of confusion.
It is often assumed that because a product is considered a medical device, for example in the USA or Canada, or in Japan, that it will also be a medical device within the European definitions. This is not the case and manufacturers should always refer to the definitions of a medical device when making any borderline determinations. Any such decision will be based on the stated intended purpose of the product and its mode of action. Manufacturers should also consult the available published guidance in order to determine whether or not their product is considered a medical device within the European Union. The available guidance is listed in Appendix 1 of this document.
In general, medical devices must have a ‘medical purpose’ which is determined by the definition of a medical device. They must also act primarily in a way that is not metabolic, immunological or pharmacological. Should they function in any way that is metabolic, immunological or pharmacological, in conjunction with having a medical purpose, they are likely to come within the remit of the regulations covering medicinal products instead. Further information on the borderline with medicinal products is available – see the list at the end of this document.
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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