Medicaldeviceslegal is proud to report its first sent in medical devices judgment, kindly sent in by James Lawford Davies from the UK life sciences law firm Lawford Davies Denoon. Many thanks James, and may many readers of this blog follow this example.

The case, The Queen on the application of JBOL Ltd and the Health protection Agency concerns a controversy between a UK company JBOL Ltd and the UK Health Protection Agency about the concept of ‘sterile’ under the EU In Vitro Diagnostic Devices Directive (“IVDD”).

JBOL produces urine containers that are sterile in the sense that the chance of a viable micro-organism being present in them is 1 in 1,000,000 or less. Urine containers are ‘specimen receptacles’ regulated as IVDs under the IVDD. The Health Protection Agency’s initial guidance note BSOP41 on “Invesigation of urine” required that “The whole specimen is collected into a sterile container and then an aliquot sent for examination”. The Agency changed the guidance in October 2009, replacing the word “sterile” with “a CE marked leak-proof container” with a footnote containing a reference to the IVDD:

“The requirements of the EU in vitro Diagnostic Medical Devices Directive (98/79/EC Annex 1B 2.1) state that such devices must “reduce as far as possible contamination of, and leakage from, the device during use and, in the case of specimen receptacles, the risk of contamination of the specimen. The manufacturing processes must be appropriate for these purposes.”

JBOL started legal proceedings against the Agency because it resisted the removal of the term “sterile” from the guidance. The Agency defended itself by arguing that the urine containers had always been subject to the mandatory standards imposed by the IVDD and that these never required sterility. The court finds that the Agency did not act unlawfully when it decided to remove from its guidance the requirement that urine should be collected and transported in sterile containers (point 31 of the judgment), that the IVDD does not require urine containers to be sterile (point 35 of the judgement) and that the Agency did not have to amend its guidance to clarify the reference to the IVDD as the Agency had not acted contrary to the IVDD by referring to it (point 36 and following of the judgment).

This case highlights the obvious problems that may arise when national regulators start clarifying EU medical devices requirements that are already quite detailed and were subject to a harmonised standard (EN 14254), especially when companies have been relying on the national guidance issued, even if this imposes stricter requirements than EU law prescribes. In that case a national agency is in a difficult position because EU law prescribes that it cannot deviate from EU law, while the companies will argue that they have relied on the agency’s guidance in good faith. In this case the UK courts take the side of the agency, allowing it to bring its guidance in conformity with EU law, even if this changes things on a national level for companies relying on the national guidance.