Once again, new scandals on unsafe medical devices shake the
European Union, as unveiled by the International Consortium of
Investigative Journalists. Socialists and Democrats in the European
Parliament took the lead to ensure the safety of medical devices
and implants back in 2012 following the first scandals on dangerous
breast implants and hip replacements. Six years later, the
new legislation passed by the European Parliament is supposed to
come into force in 2020, but some member...Request free trial
Once again, new scandals on unsafe medical devices shake the
European Union, as unveiled by the International Consortium of
Investigative Journalists. Socialists and Democrats in the European
Parliament took the lead to ensure the safety of medical devices
and implants back in 2012 following the first scandals on dangerous
breast implants and hip replacements.
Six years later, the new legislation passed by the European
Parliament is supposed to come into force in 2020, but some member
states have already announced that they may not be ready.
S&D spokesperson on health, Miriam Dalli MEP,
said:
“The European Parliament worked very hard to tighten the
requirements for medical devices and we want it to be implemented
as soon as possible. On the contrary, we should speed up the
implementation. We call on the European Commission to make sure
that member states have all the resources and capacity to have the
new system running on time.
“The new law will set rules for medical devices right through
from design and manufacture to authorisation and post-market
monitoring. All medical devices from plasters and hospital beds to
breast implants, hip replacements and pacemakers will be
covered.
“Devices will be fully traceable with the introduction of a
Unique Device Identification (UDI) number, so in the future we will
know which device has been implanted into which patient. An alert
system between EU member states has also been introduced to make
sure that once an unsafe product has been detected in one country,
other member states will know right away and warn potential
affected patients."
Biljana Borzan MEP, the S&D spokesperson on in-vitro
diagnostic devices, added:
“We already identified the short-comings of the existing
legislation. If a disease is not detected or the wrong therapy is
prescribed, the consequences for the patient can be fatal.
Our group pushed for better regulation of diagnostic medical
devices. Now the system of expert pre-market scrutiny for new
innovative types of high-risk devices must be quickly be put in
place.
“The Parliament also pushed for tighter rules for
notification bodies, to make sure that we end ‘certificate
shopping’: currently we see producers going from one notified body
to another whenever their product’s certification is rejected by
one of the private conformity assessment bodies. It is important
that all existing assessment bodies - over 50 - have the capacity
to properly examine each product, and this may include employing
more experts.”
Note to the editor:
Medical devices are currently regulated in the EU by three
Directives dating from 1990: the Directive on active implantable
medical devices; the Directive on medical devices; and the
Directive on in vitro diagnostic medical devices. After the
Parliament adopted its first reading position in 2012 on the new
regulation, it took the European Council years to reach a position;
trilogues only started in 2015 with a final agreement achieved in
June 2016.
