On 29 March 2017, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a new guidance (hereafter “Guidance“) concerning the Own Brand Labelling of medical devices in the United Kingdom. The Guidance, which is expected to have substantial consequences for the current arrangements between Own Brand Labellers (OBL) and “Original Equipment Manufacturers” (OEM), is intended to replace the MHRA guidance titled “Own Brand Labelling and Rented Products, Bulletin No. 19” last amended in June 2011.
The publication of a revised Guidance on Own Brand Labelling, which is now designed by the MHRA as “Virtual Manufacturing”, was a necessary result of the Commission Recommendation 2013/473/EU of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices which changed the EU expectations for OBLs.
The Recommendation clearly provides that OBLs should be treated as the legal manufacturers of the medical devices which are placed on the EU market under their own name. As a consequence, notified bodies should be able to conduct unannounced audits of all the critical subcontractors and crucial suppliers of the OBLs. This includes the OEM and the OEM’s own critical subcontractors and crucial suppliers. In addition, the Commission Recommendation required that OBLs hold their own Technical Files for the medical device and, where applicable, their own quality management system. A summary of the OEM Technical File is no longer sufficient.
This new MHRA Guidance is intended to reflect these new requirements. It is also intended to explain how the MHRA expects Virtual Manufacturers to meet these requirements.
New expectations for the technical documentation which must be held by Virtual Manufacturers
The new Guidance clearly provides that all manufacturers are expected to hold a full Technical File of the medical device that they will place on the UK market. This technical documentation must be integrated into the Virtual Manufacturer’s quality management system which, where applicable, must also be audited by a notified body.
The Guidance explains that, in the case of Virtual Manufacturing, where the Virtual Manufacturer does not hold the rights to a medical device design, the notified body and the MHRA may accept a Technical File from the Virtual Manufacturer that contains redacted proprietary information from the OEM. However, redacted information should not be essential for the purposes of assessment by the notified body or the MHRA of compliance by the medical device with the EU and UK regulatory requirements.
The MHRA also provides examples of what can be considered to constitute proprietary information:
- Unique material formulae or ingredients which are specific to the medical device and not in general use which are of high commercial and intellectual benefit to the OEM;
- Unique manufacturing processes which have been designed by the OEM and give them a competitive advantage in the market place;
- Technical drawings and technologies (applicable where a patent is also being applied for) but not yet granted;
- Software algorithms.
The Guidance also underlines that justification for the redactions proposed by the OEM to its proprietary information must be documented. Moreover, the top level information provided should be sufficient to understand the medical device and any associated risks.
The MHRA Guidance also requires that Virtual Manufacturers holding redacted Technical Files conclude contractual arrangements permitting full disclosure by the OEM to the Virtual Manufacturer’s notified body of all applicable information without the further need for agreements to be put in place between the notified body and the third party OEM.
The Guidance lists the other provisions which should appear in these agreements between OEM and Virtual Manufacturers.
Impact for Virtual Manufacturers
The Guidance will be applicable from 1 September 2017. By this date, the MHRA expects all Virtual Manufacturers to hold full Technical Files for their medical devices. The MHRA also expects UK notified bodies to rely on this Guidance when auditing Virtual Manufacturers.
Virtual Manufacturers have, therefore, only five months to contact OEMs, negotiate new agreements containing the provisions listed in the MHRA Guidance and obtain a full or redacted version of the Technical File for each medical device that they market under their own name in the EU.
Although the Guidance provides useful information, it is currently unclear whether this new MHRA Guidance will be supported by other EU Member States’ competent authorities.