Certification of devices
68. In Europe, medical devices are not licensed
by a Regulatory Authority.
Instead they carry "CE marking to denote the manufacturer's
claim that the device is safe and fit for its intended purpose
and meets all the requirements of the Medical Devices Regulations".
CE marking is granted by 60 Notified Bodies throughout Europe.
Issues of commercial confidentiality limit public disclosure of
which body has licensed which product; moreover, conformity assessment
documentation is not freely in the public domain.
The MDA describes its function as being to "take all reasonable
steps to protect the public health and safeguard the interest
of patients and users by ensuring that medical devices and equipment
meet appropriate standards of safety, quality and performance
and that they comply with relevant Directives of the European
69. Mr Balen voiced his concern that "the introduction
and use of the CE Mark as an aid to harmonisation of standards
in the EC may have had the effect of reducing the standards in
He argued that the CE mark did not in any way represent a guarantee
of safety such as consumers might expect. A further structural
weakness was that notified bodies could be chosen by manufacturers
anywhere in Europe: the consequence of this was that companies
could "hawk themselves around Europe" targeting the
least stringent body for certification, then freely market products
throughout Europe "without further control".
Finally, notified bodies, "as profit centres are also likely
to be under pressure not to fail products thereby risking a reduction
in their income".
70. We put these concerns to the MDA and the Minister
and they agreed that there were serious flaws in the system. They
acknowledged that the presence of the CE mark might be misconstrued
as a guarantee of safety.
They agreed with us that the fact that these products could be
marketed without clinical trials meant that the women actually
purchasing the implants were themselves constituting a sort of
clinical trial. The MDA - working in conjunction with other regulatory
bodies - has secured a review of the operation of the European
Directive for Medical Devices. Measures "under active discussion"
include the establishment of a European Notified Body oversight
group and the reclassification of breast implants into the "highest
risk" product category (currently they are classed as "medium
risk"), moves the MDA supports.
Such a reclassification would afford the most stringent controls
under the regulations and would require the Notified Bodies to
assess the manufacturer's design dossier for each device.
71. The UK is also leading the drive to have a co-ordinating
body which would seek to ensure uniform standards for all of the
Notified Bodies scattered around the EU.
72. We commend the DoH and MDA for their efforts
to have breast implants reclassified as high risk devices and
their push to achieve uniform standards in Europe's Notified Bodies.
However, we feel that the current regulatory system is deeply
flawed and may need an even more radical overhaul. We were very
unhappy that the manufacturers themselves could choose which body
to apply to for certification. We also think the manufacturers
should be obliged to have a robust system in place to collate
data relating to adverse incidents. In parallel with this, we
think the MDA should operate a surveillance system along the lines
of the yellow card system applying to drugs. This could lead to
the construction of a central register, allowing early detection
of problems. We would prefer a more precautionary system to be
in place, where products could only come on to the market once
they have been licensed by a regulatory authority which was itself
satisfied that proper clinical trials had been carried out.