Following the PIP breast implants and faulty HIV test scandals, it was clear that the medical device and in vitro test industry could not continue as if nothing had happened. It was clear that the existing regulations were no longer fit for purpose and the scandals were simply the tipping point.
I don’t think anyone could have predicted that it would take almost five years to deliver change. Yet one has to bear in mind the complexity of the issue. The EU’s medical device industry is huge, employs many thousands of people and generates over a hundred billion euros in revenue per year. Any changes to the legislation would have to be implementable and proportionate.
Working on this report has been the most technically demanding process of my mandate. The Parliament completed its work on the legislative changes in the first half of 2014, but we had to wait two years for the member states in the Council to produce their own negotiating position.
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During this time, I was worried we would have a new scandal somewhere in the EU and that people would be hurt. Fortunately, this did not happen and ultimately, we were able to conclude negotiations that spanned ten months and two EU Council presidencies.
One of the major amendments to the old system is the strengthening of the provisions on the designation, organisation, monitoring and expertise of the Notified Bodies conducting the conformity assessment and certification for all devices on the Union market.
Some of the additional provisions relate to the permanent availability of sufficient administrative, technical and scientific personnel within Notified Bodies to allow them to successfully conduct their conformity assessment activities.
The joint assessment of designation, continuous monitoring and annual re-assessment of Notified Bodies with on-site audits, including unannounced visits, are measures that will ensure the continued quality of expertise and observation of legal requirements by all Notified Bodies in the Union.
A major improvement in the new legislation worth highlighting is that notified bodies will be obliged to undertake unannounced inspections at production sites. For high-risk devices, it will no longer be sufficient to simply check the papers; controls have to be on the spot. This is probably the most important development in helping prevent future scandals.
Expanding on the Commission’s initial proposal for a scrutiny mechanism for the highest-risk in -vitro devices, these will be subject to an extra conformity check from a European reference laboratory. This was one of my absolute priorities, and negotiations on this went down to the wire, but in the end the Council agreed.
We introduced a provision for a second-level check of the highest risk innovative devices. This is a special procedure during the conformity assessment and before certification, where no common specifications are available for these devices and where it represents the first certification for that specific type of device.
In an overall decentralised system of conformity assessment and certification in Europe, this new provision aims to ensure that, when it comes to the highest-risk devices, there is an additional level of supervision on EU level. This will be conducted by experts re-evaluating the clinical evaluation assessment reports of the notified bodies for such devices.
As well as strengthening the authorisation procedures, one of the key pillars of the new proposal is an enhanced overall system for the traceability of devices, vigilance and post-market surveillance. This will ensure constant monitoring and allow for a swift reaction should problems arise.
In addition to the Commission proposal, we introduced an obligation for manufacturers, proportionate to the risk class of the device, to plan, establish, document, implement, maintain and update a post-market surveillance system for each type of device. This will gather, record and analyse all relevant data associated with the safety of the device throughout its lifecycle.
The manufacturers’ liability insurance was a red line for the Parliament, given recent experiences with defective devices and the consequences for affected users. This had not been addressed in the Commission proposal and the member states resisted our attempts to introduce it.
The Parliament stood firm, and a provision was added requiring manufacturers to – in a manner that is proportionate to the risk class, type of device and the size of the enterprise - have measures in place to provide sufficient financial coverage in respect of their potential liability. These are some of the most important changes introduced that will make patients and users safer and retain the competitiveness of European medical devices industry.
However, there is concern that a lack of resources within the Commission, the member states and their authorities may lead to further delays the legislation operational. Among other things, new regulations provide for the Commission to adopt numerous delegated and implementing acts.
We therefore have sent a letter to President Juncker to ensure that adequate and appropriate resources are allocated to ensure that the development of secondary legislation and guidance on medical devices, as well as the establishment of the EUDAMED centralised system, are all completed by any deadlines given in the regulations.