Useful advice for virtual manufacturers of medical devices.
Earlier this year, the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) published an updated version of their guidance for virtual manufacturers of medical devices. The guidance reflects the changes following from the UK’s withdrawal from the EU. Prior to Brexit, the UK complied with the rules on medical devices applicable in the EU. Against this background, the guidance may also provide a useful basis for assessing which obligations so-called virtual manufacturers of medical devices in e.g. Denmark are subject to.
In the guidance, the MHRA describes the concept of “virtual manufacturer”. A virtual manufacturer is an organisation that fully sources its own named product from another company, which has designed and manufactured an identical UCKA/CE/CE UKNI marked product.
By placing their own name and address on the product, the virtual manufacturer takes on the legal responsibility for the medical device. The virtual manufacturer is regarded as the actual manufacturer in accordance with the UK legislation on medical devices.
Virtual manufacturers must live up to multiple requirements. First and foremost, they must have a quality management system that is audited on an ongoing basis by the approved body responsible for safeguarding the quality of medical devices. Furthermore, they are expected to hold the full technical documentation for the device, which may also be reviewed by an approved body. The requirements must be met even where the manufacturing has been outsourced in full or in part to sub-suppliers.
In practice, the requirements for virtual manufacturers correspond to the requirements generally made of standard manufacturers of medical devices.
Technical documentation requirements
All virtual manufacturers are expected to always hold full technical documentation in order to demonstrate that the medical device that they place on the market, under their own name, meets the regulatory requirements.
The technical documentation should be fully integrated into the quality management system and should contain all the data relevant such as labels, instructions for use and risk assessments.
Virtual manufacturers must be in possession of the formulae, ingredients, algorithms, etc., used in the manufacturing by the supplier. If the virtual manufacturer only holds parts of the relevant information, a reasonable cause for this must be presented. A sufficient level of information should always be provided such as to ensure that the authorities understand the medical device and any associated risks.
Requirements for agreements between virtual and original manufacturers
The guidance describes certain minimum requirements for contractual agreements entered into between an original manufacturer and a virtual manufacturer of medical devices.
First of all, a direct link must be established between the original and the virtual manufacturer. Furthermore, arrangements must be made for who is responsible for post-market surveillance of the devices and reporting of adverse incidents. In addition, it must, among other things, be arranged whether an obligation exists to give notification of changes to the medical device to the other party, whether a non-competition clause is to apply for the virtual manufacturer and finally what authority the original manufacturer has in respect of the approved bodies.
Introduction of two new certificates
Finally it appears from the guidance that MHRA has introduced two new certificates in the form of the UKCA mark, which is valid in Great Britain as well as the CE UKNI marking, which is required in Northern Ireland. The certificates have been introduced for certain goods being placed on the UK market.
The CE marking will continue to be recognised in Great Britain until 30 June 2023.
From 1 July 2023, all new devices placed on the Great Britain market will need to conform with UKCA marking requirements.
Click here to read more about the guidance.