Device information

This screen is the device label. It carries the information required by Part II of the UK Medical Devices Regulations 2002 (essential requirement 13) for a Class I medical device placed on the Great Britain market.

MD UKCA Manufacturer

Before release: replace the three marks above with the correct artwork. The UKCA mark has mandatory proportions and a 5 mm minimum height set out in the government's UKCA marking guidance. The MD and manufacturer symbols come from BS EN ISO 15223-1, which you need a licensed copy of to reproduce accurately. The boxes here are placeholders so the layout is right, not compliant artwork.

Device name

Software version

Release date

Classification

Class I, UK MDR 2002. Conformity self-declared by the manufacturer.

Manufacturer

Address

Contact

MHRA registration

Intended purpose

MediTime Pro is standalone software intended to record the times at which doses of over-the-counter paracetamol and ibuprofen are given, for up to five named individuals, and to display the time remaining until the next dose would be due together with the number of doses already recorded against the maximum stated on the product labelling.

Its purpose is to help the user avoid giving a dose sooner than the labelled interval allows, or giving more doses in 24 hours than the labelling permits.

It applies limits on the timing and number of doses only. It does not determine, recommend, check or display the amount of any dose.

Draft wording, not yet signed off. This text must match section 2 of the intended purpose statement in the technical file exactly. If you change one, change the other, and both app files that carry it.

Who it is for

MediTime Pro is used by an adult with no clinical training, at home. That covers someone managing their own over-the-counter pain relief, and a parent or family carer giving it to someone else in the household, including a child. It is not for clinical settings or for regulated care providers.

What it does not do

It does not decide how much to give. It tracks when doses were given and how many, never the amount. Amounts come from the packet, and for a child they depend on age and weight.
It does not know whether a dose was actually taken. It only knows that someone pressed the button.
It does not detect an overdose, and it cannot stop one.
It does not send alerts or reminders when you are not looking at it.
It does not keep a history. Records older than 24 hours are deleted automatically and cannot be recovered.

Warnings

The timer is only as accurate as what you enter. If a dose is given and not recorded, the app will show a longer gap than there really was.
The app does not transfer between devices. Records on a phone are not visible on a tablet, so two people recording on two devices will each see an incomplete picture.
Clearing your browser data, using private browsing, or reinstalling the app deletes all records with no warning.
The built-in counts and intervals are the standard over-the-counter limits: paracetamol four doses in 24 hours, at least four hours apart; ibuprofen three doses in 24 hours, at least six hours apart. These are limits on timing and number, and they are the same whether the medicine is for an adult or a child.
The amount in each dose is not the same, and the app knows nothing about it. A child's dose depends on age and weight. Read the packet for the right amount, every time, and ask a pharmacist if you are unsure.
The counts assume a standard over-the-counter product taken as labelled. They are wrong for prescription-strength products, and for combination products containing paracetamol or ibuprofen alongside something else.
The app shows paracetamol and ibuprofen as two separate trackers. That is a layout, not a recommendation. It does not suggest giving both, or alternating between them.

Do not rely on this app if

You have been given a dosing schedule by a doctor or pharmacist that differs from the packet. Follow theirs.
You take any other medicine containing paracetamol or ibuprofen, including cold and flu remedies. The app cannot see those.
You have liver or kidney problems, a stomach ulcer, asthma made worse by anti-inflammatories, or you are pregnant. Ask a pharmacist first.
The person is a baby under three months old. Get medical advice before giving either medicine, whatever the packet says about older children.
You are treating a young child's fever and are thinking about using both medicines. Current NHS guidance is to treat distress rather than temperature, and not to give both at the same time. Follow that or your pharmacist's advice, not the fact that this app has two trackers.

If you think too much has been taken

Do not wait to see if symptoms appear. Paracetamol overdose can cause serious liver damage with no early warning signs. Contact NHS 111, or call 999 if the person is unwell. Take the packet with you.

Reporting a problem with the app

If the app behaved in a way that could have led to harm, or did lead to harm, tell the manufacturer at the address above. Please include what you did, what the app showed, and the date and time.

You can also report a problem with a medical device to the MHRA directly through the Yellow Card scheme at yellowcard.mhra.gov.uk.

Full instructions

The full instructions for use are on the Instructions screen. The terms you agreed to when you first opened the app are on the Agreement screen.