Freedom of Information request on computer-controlled methadone dispensing systems (FOI 21/1043)
Published 27 April 2022
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5th October 2021
FOI 21/1043
Dear
Thank you for your information request, dated 13 September 2021, where you asked “if any computer-controlled methadone dispensing systems, now classified as Class Im devices under MDR meet the legal requirements to be a registered medical device.
If they are not are you aware of any work being done to ensure all systems on the market are compliant with the regulations?
These systems are: Methameasure Methsmart Methasoft ”.
No determination on classification has been made on the products identified as Methameasure, Methsmart and Methasoft.
I can confirm MHRA does not hold any information with regards to the manufacturer and the method of classification or placing on the market.
Please note, this enquiry only covers aspects related to the device/system not medicines.
If the information were available for public scrutiny then you could review the following MHRA webpage: Public Access Database for Medical Device Registration (mhra.gov.uk)
If it was found that there was an ongoing investigation, so as to not influence that investigation, we would be unable to provide information based upon section 30 (investigations) and section 43 (commercial interests) of the Freedom of Information Act.
For general information on the registration requirements you may find helpful information published on Register medical devices to place on the market - GOV.UK (www.gov.uk)
Furthermore, under the current Medical Devices Directive (MDD 93/42 EEC) pill dispensers intended to identify which day medication should be taken or to act as a ‘reminder’ to take pills on a specific day or time are not regarded as being medical devices.
For a medication reminder app to be considered a medical device the app would need to be specifically intended to e.g. alleviate/compensate for an injury or handicap or if it calculated a drug dose to compensate for missing medication.
Under the MDR, software that provides information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa.
Finally, please be aware that the MHRA has launched a public consultation on the future of the medical device regulation. For more information please visit MHRA launches public consultation on future of medical device regulation - GOV.UK (www.gov.uk)
Please note that whilst we are willing to give any help and advice we can, any views given by us on the interpretation of the legislation represent our best judgement at the time, based on the information available. Such views are not meant to be a definitive statement of law, which may only be given by the Courts. Accordingly we would always advise you to seek the views of your own professional advisors.
If you have any further queries please reply to this email.
Kind regards,
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU