Do You Want To Find Out About CE Marking An App? Find Out More Here

There has been a veritable explosion in the number of mobile apps which act as aids to patients and clinicians – everything from medication reminders to apps which calculate drug dosage. In this brief overview we look at CE Marking an App.

So when is an app a medical device?

The first question to ask  is ‘does my app fall under the definition of a medical device i.e. does it have a medical purpose?’ To that end, you need to review the relevant definition, as per the European Medical Device Directive 93/42/EC definition:

‘Medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
  • investigation, replacement or modification of the anatomy or of a physiological process,
  • control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.’

The answer to this question is sometimes difficult to determine for an app and unfortunately there is limited guidance available for the app developer. According to the MHRA, (the regulatory authority who have oversight of medical devices in the UK), the words and phrases listed below are all likely to contribute to a determination by the MHRA that the app they were associated with is a medical device;

Amplify, analysis, interpret, alarms, calculates, controls, converts, detects, diagnose, measures, monitors.

The MHRA further state that the following types of software functionalities are likely to result in an app or software being defined as medical devices:

  • decision making software that provides a calculation, decision support algorithm e.g. dose calculation which will aid a clinician are likely to fall within the scope of the medical device directive,
  • apps which are accessories to medical devices e.g. measurement of blood pressure, heart rate
  • software which collects information entered by the User, measured by the app or collected by a point of care device where the output is likely to affect treatment decisions

….and these functionalities are not likely to result in the app being defined as medical devices:

  • software used to book appointments, request a prescription or have a virtual consultation
  • software that provides general disease information
  • decision support software which provides information to a clinician but where the clinician ultimately relies on their own professional judgement

If you have determined that your app is a medical device, the next step is to determine what the device classification is under the Medical Device Regulations. There are 4 classifications ranging from Class I (lowest risk), Class IIa (low-medium risk), Class IIb (medium-high risk) to Class III (highest risk).

The European Commission guidance document MEDDEV 2.4/12 provides information on how to classify your device. Software apps are considered to be ‘Active’ devices under the definitions provided in the Medical Device Directive, meaning that they rely on an external energy source for their operation. Therefore, Rules 9, 10 and 12 of Annex IX of the Medical Device Directive apply. Depending on the risks associated with use of the app, the app will be classified as Class I, IIa or IIb. The procedures and requirements for demonstrating conformity with the directive increase with increasing risk classification. Compliance of Class I devices is based on a self-declaration by the manufacturer, whilst all other devices require use of a notified body to assess compliance.

We are medical device regulatory specialists.  We can help you with your medical device issues.  Complete the details below or call us today on 00353 52 61 767 06

  1. Medical device stand-alone software including apps. MHRA Guidance, 8 August 2014
  2. Classification of medical devices, MEDDEV 2.4/1 rev. 9, June 2010