On 26 September, the European Commission submitted formal proposals for the revision of the Medical Devices Directives 90/385/EEC and 93/42/EEC (MDD) to the Council and European Parliament. The MDD is intended to be revised as a EU Regulation. See our previous Law-Now for the key changes and likely implementation dates.
The proposals include specific provisions directed to regulation of software and in this Law-Now, we consider the impact of the proposals on this. Companies active in the e-health field should take note of the following:
Definition of a Medical Device
- The definition with respect to software has been amended to arguably broaden the number of products that may qualify as medical devices. The existing definition reference to “software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application” under the MDD has been replaced by only “software...intended by the manufacturer to be used, alone or in combination, for human beings...” in the draft EU Regulation.
- Under both the MDD and the draft Regulation, the software must be intended to be used for one or more of the existing listed (medical) purposes but the Regulation also includes re-worded and additional medical purposes of “control or support of conception” and “disinfection or sterilisation” of any of the products mentioned in the main part of the definition.
- As under the current legislation, it is important to remember that any software which is intended by its manufacturer to be used together with one or several particular devices “to specifically enable or assist” the device(s) to be used in accordance with its/their intended purpose(s) will also be regulated as a medical device itself. This will therefore have potential to catch software intended for use in connection with remote monitoring of patients.
New Essential Requirements for CE Marking
- There are new essential requirements for software (both incorporated and standalone) regarding safety and performance aspects which are set out in Annex I, section 14, of the draft Regulation.
- Devices that incorporate electronic programmable systems, including software, or standalone software that are devices in themselves, must be designed to ensure “repeatability, reliability and performance according to the intended use”. In the event of a single fault condition, appropriate means must be adopted to eliminate or reduce as far as possible and appropriate consequent risks.
- For devices that incorporate software, or for standalone software that are devices in themselves, the software must be developed and manufactured according to the state of the art taking into account the principles of development life cycle, risk management, verification and validation. Verification and validation are likely to be the most challenging issues for CE marking software developers in the medical field.
- There is also an app-directed requirement for software intended to be used in combination with mobile computing platforms to be designed and manufactured taking into account the specific features of the mobile platform and the external factors related to its use. There is however no definition of “mobile computing platform” in the draft legislation and this will presumably encompass all forms of handheld devices.