The European Commission is about to present proposals to tighten up legislation on medical devices, such as hip and knee replacements. But following the recent PIP breast implants scandal the European Parliament is pressing for rules on implants to also be stepped up at European level.
On Monday 17th September, Linda McAvan, Labour MEP for Yorkshire and the Humber, who has been leading the campaign for a pan European register for breast implants, and Jacqueline Minor, Director of Consumer Affairs (European Commission's Directorate General for Health and Consumers) briefed an audience of stakeholders and specialist media on the regulation that is likely to emerge for the sector later in the Autumn.
The briefing took place at Europe house in London. Graeme Perks, BAPRAS Vice President, reports from the specialist briefing:
The meeting was well-attended with representatives from MHRA, BAAPS, UKAAPS, Transform, Allergan, Silimed, BMJ, BBC Radio, a solicitor representing PIP victims and an Implantable Device Manufacturer representative, amongst many others.
Jacqueline Minor presented the update of the regulatory framework. I learned that the proposals will be presented on 26th September 2012 - they will go before European parliament with inevitable amendments, before a working group is established. They aim to have it "wrapped up" by 2014.
There are three directives: ‘active implantables’, ‘diagnostic devices’ and ‘remaining’. The primary goal is patient safety and so all breast implants and fillers are now included in the legislation. There had been some ambiguity previously when the implant was not for therapeutic benefit, it was excluded!
They do not wish to stifle innovation in healthcare devices, which are seen as a European success story. There is to be a UDI (Unique Device Identifier), which is intended to make tracking devices more transparent, and money is forthcoming for a database of all implantable devices (running into hundreds of thousands). Note – this is not the same as an implant registry, which the speakers agreed is aspirational but for which the EU has no legislative power.
The two proposals, as I understood them, would be:
1. Each member state is to nominate a "Designated Body" which would be responsible for vetting new implantables (there is no plan to look at existing devices as far as I can tell). At present there are 74 Designated Bodies in the EU with no uniformity, and no mandate for all UK inventions to pass through the UK "Designated Body". This will change in pursuit of uniform standards. Audit of these Designated Bodies will be by the Commission and representatives from 2-3 external members of other Designated Bodies. Failure in this process will result in the refusal to allow vetting.
2. A High Risk Scrutiny Procedure. All devices with potential safety issues will be scrutinised beyond the Designated Body, with the manufacturer presenting to the Commission, which has 28 days to call the file in. Clinical data and post market surveillance must be built into the submission. It was stated that 3-9 months would be the expected time frame for assessment by the Regulatory Body.
Manufacturers will have responsibility for the reporting of untoward incidents to National Bodies (eg; MHRA), who then report upwards to the EU. Naturally it will be necessary for all professionals to be active in our own reporting of such events.
In summary, there is no EU ability to push for mandatory reporting but the BOA National Joint Register was held to be a good example of what can be achieved (over 90% patient compliance on the last report). Linda McAvan was optimistic that in the light of PIP experience the public would appreciate the value of an opt-out register like the NJR
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