§ Lord Kennetasked Her Majesty's Government:
What are the implications of the completion of the EC internal market in 1992 for the commercial pro vision of experimental surgical and other medical procedures; and whether such procedures may be patented.
§ Baroness HooperUnder the terms of draft directives or the regulation of medical devices within the EC post-1992, all medical devices will normally require a special CE mark as a condition of entry to the single European market to indicate conformity with specified essential requirements. However devices intended for experimental clinical investigations could be made available to specialist doctors for that purpose without the CE mark provided a statement was submitted to the competent authorities at least 60 days before the start of the investigations. This statement would have to provide details of the devices to be used, an investigation plan and timetable, the responsible doctor and institution, and confirmation of arrangements to ensure the devices provided full protection of the health and safety of the patient. For custom-made research devices documentation would have to be provided enabling the design, manufacture and performance of the product to be understood, so as to allow the competent authority to assess conformity with directive requriements. Anyone wishing to protect a patent would be well advised to lodge their patent application in advance of this notification procedure and also to ensure that the notification was explicitly done on a strictly confidential basis on an assurance from the competent authority that it would not be published further and would be used solely for the purpose of the directive.