Recently, the Daily Telegraph newspaper and the British Medical Journal conducted an investigation into European medical devices regulators and uncovered some unscrupulous practices. The investigators reported that regulators in certain countries consider the licensing process to be a pure "money-making business" and have (purportedly) advised Chinese and Indian companies to falsely mark their goods as "Made in Europe" in order to obtain regulatory approval.
It is hoped that the concerns raised by such investigations and the broader concerns raised by the recent PIP breast implants scandal will be addressed through the European Commission's proposed amendments to the system for regulating medical devices, implemented through new Regulations concerning Medical Devices and In-Vitro Diagnostic Devices. The new Regulations were published on 26 September.
As part of the proposals, the European Commission has proposed that a "scrutiny procedure" be applied in addition to the usual national approval processes for medical devices. The scrutiny procedure, proposed in Article 44 of the latest draft of the Medical Devices Regulation ("MDR"), allows for a committee of Member State authorities to select certain product files for additional review after they have been approved by national regulators. Initially, the scrutiny procedure would be restricted to class III devices (although this may later be expanded to other classes) including:
- Devices where concerns over public health exist;
- ‘Novel’ technologies (which is not yet defined in the MDR); and
- Files from regulators with a history of significant discrepancies.
Although the revisions to be introduced by the MDR have generally been welcomed, this specific proposal has been strongly criticised by Eucomed and the Association of British Healthcare Industries. The ABHI claims that this change will create "a system that causes unnecessary delays in products coming into the market" which "will harm patients by limiting access to new treatments".
The MHRA recognises that changes to the regulation of medical devices on a pan-European level are needed, and has previously recommended better collaboration between national regulators. On 12 November, the MHRA launched a consultation to gather views on how the proposed legislative changes will impact UK stakeholders. Responses to this consultation are due by 21 January, with a summary of the responses to be published shortly thereafter.