Europe plans to strengthen surveillance system for medical devices, MPs are toldBMJ 2012; 344 doi: https://doi.org/10.1136/bmj.e4179 (Published 15 June 2012) Cite this as: BMJ 2012;344:e4179
A stronger system throughout Europe for checking medical devices and implants and how they are performing is likely to be agreed in revised regulations.
MPs on the parliamentary Science and Technology Committee heard some hints of what changes are coming from various witnesses on 13 June as part of their inquiry into regulation of medical implants.
The inquiry follows the scandal last year over discredited and now bankrupt French manufacturer Poly Implant Prosthèse (PIP), which used non-medical grade silicone in breast implants that were given to around 47 000 women in the UK.1 2
Jacqueline Minor, director of consumer affairs at the European Commission, giving evidence, spoke about the commission’s plan to review the directives that make up the current medical device regulatory framework in Europe.
“These directives have been in place for about 20 years,” said Minor. “They have been amended on specific points, but we believe the time has now come for more far reaching revision.”
After several consultations, the commission was due to reveal its proposed changes in September, she said. After the commission’s full process, new regulations could be adopted by the end of 2013 and be fully implemented by the end of 2014-15.
Under the proposals, new regulations would be applied that do not need individual countries to pass legislation—thus avoiding problems over interpretation and application of rules.
The new approach would also deal with oversight of notified bodies—the certification bodies that conduct conformity assessments of devices before they are allowed to be used—the way they carry out their conformity assessments, transparency, and post market follow-up and surveillance.
MPs on the committee asked Kent Woods, chief executive of the United Kingdom’s Medicines and Healthcare products Regulatory Agency, his opinion of any of the known proposals to change the directives.
Woods said: “We would wish to see, and I think the revisions will address this, a greater strengthening of the post market surveillance process, but also in detail, improvement in the way that notified bodies confer CE marks.”
Greater transparency in the system was crucial, he argued, adding: “The criticism has rightly been made that under existing arrangements there are obligations of confidentiality on those who run the system and we find this frustrating and unhelpful.
“I think the general public and the health professions would wish to be able to see more of the evidence underpinning the award of a CE mark and the evidence emerging from post market surveillance and all this can be incorporated into the revision of the directives.”
MPs asked the witnesses their opinion of the possibility that there may be greater regulation of devices and implants, but for it to be more centralised within Europe and under a new body.
Earl Howe, parliamentary undersecretary of state for quality at the Department of Health, also giving evidence, said: “We would prefer to see a model involving much more efficient cooperation between member states.
“If we can get greater sharing of data between member states, maybe even have an EU portal where data can be fed in when there is an adverse report on a device so that it is clearly on view to all member states, I think that would be much more efficient, more effective, and much less cumbersome.”
On 14 June MEPs adopted a resolution calling for a series of measures to prevent a recurrence of the PIP implants case. The resolution calls for the introduction of a breast implant register in each member state and an implants recipients “passport” giving the characteristics of the implant and its potential adverse effects. The registers, says the resolution, should link up with each other so that information can be exchanged when needed, for example, if there are important defects.
MEPs also back more stringent checks, inspections, market surveillance, and information sharing on adverse effects though a single European database on medical devices on the market.
Cite this as: BMJ 2012;344:e4179