In March 2017, the Medicines & Healthcare Products Regulatory Agency (MHRA) has issued revised guidance for manufacturers and Notified Bodies. With this guidance MHRA establishes the term “virtual manufacturing” to replace ‘Own Brand Labeling (OBL)’.
Virtual Manufacturer is the natural or legal person who places a device on the market under their own name or trademark despite not undertaking the design or manufacture of the medical device itself.
Virtual manufacturers can no longer refer to the Quality Management System (QMS) or the technical documentation held by the Original Equipment Manufacturer (OEM), instead they are now expected to have their QMS audited and technical documentation reviewed by a Notified Body, whilst they hold the full technical documentation for any product they place on the market under their name.
The MHRA guidance replaces the agency’s previous OBL guidance, and its requirements come into force on 1 September 2017. All virtual manufacturers, including those of Class I medical devices, are required to comply with the new requirements.
Implementing the new guidance
Where the device requires Notified Body certification:
- LRQA will audit the QMS of the virtual manufacturer
- the virtual manufacturer is expected to hold full technical documentation which must include a statement drawn up by the virtual manufacturer indicating; the virtual manufacturer fully understands all the documentation provided and accepts full legal responsibility for the devices
- LRQA shall review the full technical documentation held by the virtual manufacturer.
Where the device does not require Notified Body involvement, the virtual manufacturer is required to:
- hold the technical documentation for their medical devices available for scrutiny by the Competent Authority
- meet relevant registration requirements (e.g. for Class I devices, IVDs etc.).
The guidance indicates that as the manufacturer under the medical device legislation, the virtual manufacturer is also required to sign a Declaration of Conformity that the devices concerned meet the requirements of the Medical Device Directives.
Virtual manufacturers shall need to ensure an appropriate contract is in place with the OEM. As a minimum, the contractual agreement should contain the following:
- 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
- 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
- The contract should include the fact that the virtual manufacturer may not enter into another contract with another virtual manufacturer for the same device
- Provision for the OEM 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, to maintain and provide to the virtual manufacturer notified body certification covering the products concerned
- For Class I devices, IVDs, provision for the OEM, to maintain and provide to the virtual manufacturer evidence of registration with their Competent Authority.
If you require more information regarding virtual manufacturing and the conformity assessment strategy for your devices, or if you would like to transfer your existing certificate to LRQA, call us on 0800 783 2179 or fill in our enquiry form.