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Notes from the Medical Device Directive and the Recast Conference, Brussels, January 2012

01 February 2012 Farah Ramadan

Last week I attended the Medical Device Directive and the Recast conference in Brussels. As the name suggests, the conference's main focus was the proposed "recast" on the medical devices directive that is being discussed in the European parliament at present. It is due to be passed this spring, so it is a very topical issue indeed.

During the first day of the conference, the implications of the recast from both the industry and regulators' perspectives were discussed in length, ending in an interesting panel discussion. Day two addressed more practical issues and topics affecting the manufacturers and regulators of medical devices and diagnostics, like re-use of devices and severe adverse event reporting.

The 'P' word
Despite the strong effort by the speakers not to focus on the PIP breast implant health scare that recently shook the medical devices industry, it was perhaps the least explicitly referred to issue, yet the most implicitly discussed and frequently masked by the 'P word' or the 'three letters word'.

However, this was not the only 'P word' that gained popularity in the conference: Pre-Market Authorization (PMA) was often linked with the scandal, or the aftermath of the scandal. Participants from the regulatory affairs departments were most interested to know what implications the PIP incidents will have on the proposed recast, and the EU regulatory framework for medical devices, especially vis-a-vis PMA.

It was very interesting to hear the thoughts of Jacqueline Minor, Director for Consumer Affairs - European Commission, on how the scandal is affecting the parliament's discussions on the proposed recast of the medical devices directive pre and post-PIP. Minor assured the audience that, when the recast was proposed before the PIP scandal, the EC did not intend to make the PMA process of medical devices more stringent and its opinion still stands.

Speakers from industry and regulators alike agreed that the scandal is the result of a fraudulent act and not a lack of PMA regulation. They believe in a system that ensures patients' safety at its heart, and going towards more strict PMA would hurt innovation and hence patients' access to high quality of care. What really undermined the reputation of the system and (mistakenly) the legislators' confidence in the current medical devices directives is not the lack of PMA, but the lack of vigilance and post-market surveillance.

It is the fact that the fraudulent act has been running for 10 years and it went completely undetected by the regulatory bodies that is most striking.

Future of Medical Devices Regulatory Framework in the EU
The good news is that the regulatory framework for medical devices is changing through the recast, to tackle shortfalls like decentralized market surveillance processes, lax control on notified bodies, and unclear/decentralized requirements for clinical evidence, in order to prevent the re-occurrence of such scandals.

The bad news is that the legislators, who are not experts in the field, might be affected by 'emotional' media concerns and lobby groups,and put the blame in the wrong basket - the PMA's basket that is. The direction of the current proposed amendments of the medical devices directive (the recast) is unpredictable in that sense. Worst case scenario: legislators will go in the direction of the pharma industry, where more clinical evidence requirements are needed for approval following more of a US model of medical devices regulations.

Best case scenario: the current system is able to prove itself as capable of protecting patients' safety, but moves towards more effective central regulatory coordination and harmonization of notified bodies.

Join our Complimentary Webcast on 7th FebruaryWe're going to be discussing the regulatory framework for medical devices across the major markets in an upcoming webcast on 7th February 2012, entitled Optimising Medical Device & Diagnostic Launches in Developed Markets. You can register here.



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