The new guidance on Virtual Manufacturing has been published by the MHRA. The document, titled “Virtual Manufacturing replaces Own Brand Labelling for medical device manufacturers” can be found here. As the title suggests, this replaces the previous OBL guidance and its requirements must be met by 1st September 2017.
One of the critical new requirements is that such manufacturers must now have their own Quality Management System audited, and their technical documentation reviewed by notified bodies. This manufacturer, now termed the “Virtual Manufacturer”, is considered as “the natural or legal person who places a new or fully refurbished device on the market under his name despite not undertaking the design or manufacture of the medical device itself”. Previously, such manufacturers got away with holding Summary Technical Documentation (STED), however are now expected to hold the full technical documentation for any product they register under their name. The documentation will then be reviewed by a Notified Body (NB) or Competent Authority (CA). In cases where the manufacturer does not hold the rights to the product design, the NB or CA may accept certain design information to be redacted, however this should be limited as much as possible and must not hinder their assessment. In such cases, the virtual manufacturer shall ensure that a mutual contractual agreement is in place with the Original Equipment Manufacturer (OEM) such that the CA may access this redacted information.
Previously, manufacturers of class I devices or IVDs were not expected to register these products. The new guidance clearly states that this is no longer the case, and such devices must be registered with the appropriate CA. The technical documentation is expected to be well integrated into the manufacturer’s quality system, with references to instructions for use, labels, risk management and so on. Furthermore, the technical documentation must include a statement by the virtual manufacturer stating that “they fully understand all the documentation provided and that they accept full legal responsibility”.
The minimum requirements present in the contractual agreement between the virtual manufacturer and OEM can be found on the MHRA guidance document, however have been provided below:
- A direct link between the medical devices being placed on the market by the manufacturer that holds the rights to the product design and the virtual manufacturer they are supplying who does not hold the design rights (e.g. by name / part number).
- Arrangements for post market surveillance and vigilance activities (i.e. details of who is responsible for what in relation to these requirements, including reporting of adverse incidents). All virtual manufacturers should ensure that incidents or potential incidents are reported and also brought to the attention of the manufacturer that holds the rights to the product design. Similarly, the manufacturer is responsible for notifying the virtual manufacturer to enable them to take appropriate action with regard to their own products.
- Provisions for post-production follow-up, including ensuring that post market clinical follow up provisions are in place.
- Arrangements for details of any changes to the medical devices to be notified to both parties.
- Provisions for unannounced audits – i.e. the notified body of the virtual manufacturer will be required to have access to any critical suppliers (including the manufacturer who holds the rights to the design).
- The contract should include the fact that the virtual manufacturer may not enter into another contract with another virtual manufacturer for the same device, i.e. a virtual manufacturer cannot be the OEM for another virtual manufacturer for the same medical device.
- Provision for the OEM (including the manufacturer who holds the rights to the design) to provide fully un-redacted information upon request of the notified body of the virtual manufacturer, without the requirement for further contractual actions between the notified body and critical supplier such as non-disclosure agreements.
- Provision for the OEM, where relevant, to maintain and provide to the virtual manufacturer notified body certification covering the products concerned.
- Provision for the OEM, where relevant, to maintain and provide to the virtual manufacturer evidence of registration (e.g. for their Class I devices, IVDs etc.) with their Competent Authority.
We understand that these new requirements may seem daunting to some who have been operating as an OBL under the previous guidance. Advena has the right expertise to guide you through this transition and build your technical documentation. For further information and guidance, please do not hesitate to contact us.