UK Medical Device Regulators Introduce “Virtual Manufacturing” to Replace OBL
EMERGO SUMMARY OF KEY POINTS:
- The UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) has redefined Own Brand Labeling (OBL) manufacturers as “virtual manufacturers.”
- UK regulators will begin requiring virtual manufacturers to hold full technical documentation of devices they sell in Great Britain starting September 1, 2017.
- Any redacted technical documentation from virtual manufacturers due to proprietary data concerns will have to be justified to UK regulators.
Recent guidance from the Medicines & Healthcare Products Regulatory Agency (MHRA), the UK’s medical device market regulator, establishes the term “virtual manufacturing” to replace Own Brand Labeling (OBL) used by companies that place their names on devices made by other manufacturers.
The MHRA guidance will replace the agency’s previous OBL guidance, and its requirements will come into force September 1, 2017. The guidance’s new requirements for “virtual manufacturers” reflect the European Medical Device Regulations’ (MDR) more stringent approach to OBL medical device companies.
How the UK defines “virtual manufacturer”
The MHRA defines a virtual manufacturer 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.”
UK regulators consider virtual manufacturers as actual manufacturers of devices on the British market because they are “placing their own name on the medical device.”
New technical documentation requirements
Prior to the new guidance, OBL companies could submit Summary Technical Documentation (STED) of their devices to their Notified Bodies, which was acceptable to the MHRA. Starting in September 2017, virtual manufacturers will have to hold full technical documentation for any and all devices they place on the UK market under their names but made by other firms known as Original Equipment Manufacturers or OEMs.
For devices that require certification by Notified Bodies, virtual manufacturers must maintain quality management systems and undergo audits; virtual manufacturers must also maintain full technical documentation on their devices for review by their Notified Bodies.
Virtual manufacturers whose devices do not require Notified Body certification must still hold full technical documentation for review by Competent Authorities.
In addition, virtual manufacturers must sign Declarations of Conformity attesting compliance with the European Medical Devices Directive.
Questions about proprietary data
The MHRA guidance does acknowledge that technical documentation requirements may complicate some virtual manufacturers’ policies for protecting proprietary information related to device design.
In cases where a virtual manufacturer does not own or hold rights for product design, Notified Bodies and Competent Authorities may accept technical files with redacted proprietary information, according to the guidance. This allowance is only possible if the redacted data in questions is not necessary for a Notified Body or Competent Authority to determine whether a device meets regulatory requirements.
Also, when a virtual manufacturer holds redacted technical documentation, that firm must have contractual arrangements in place allowing full disclosure of such information by the OEM to the virtual manufacturer’s Notified Body, obviating the need to set up additional arrangements between the OEM and the Notified Body.
Examples of proprietary data cited by the MHRA include:
- Unique material formulas or ingredients specific to the device in question and that are “of high commercial and intellectual benefit to the OEM.”
- Unique manufacturing methods and processes designed by the OEM for competitive advantage on the UK market.
- Technologies and schematics for which the OEM has not yet been granted a patent.
- Software algorithms
However, the MHRA guidance explicitly states that full redaction of all device formulas, ingredients, manufacturing methods, or algorithms by virtual manufacturers is not acceptable to the regulator.
“Where redactions are made then the justification for these redactions by the OEM must be documented and the top level information provided should be sufficient to understand the device and any associated risks,” states the guidance.