Restoring confidence in medical devices. Action Plan after the PIP scandal tightened control in Europe
23 Jun 2014 12:44 PM
The EPSCO Council has
discussed the joint actions taken by the European Commission and the Member
States to restore confidence following the scandal of defective breast implants
produced by the French PIP company. These measures were included in the Joint
Plan for Immediate Actions under the existing Medical Devices legislation (the
so-called PIP Joint Action Plan) agreed in 2012 (See
IP/12/119).
“Consumers are safer
today than they were when the PIP scandal was discovered”, said
Neven Mimica, Commissioner for Consumer Policy. “Thanks to close
cooperation between Member States and the European Commission, today's
rules on medical devices are better enforced. We succeeded in particular to
tighten the control of notified bodies. Some key improvements, however, require
a reinforced legal basis. This is why I called on the Member States to reach a
political agreement before the end of this year in order to allow rapid
adoption of this vital dossier.”
The PIP scandal made it clear
that immediate improvements in the oversight of medical devices were needed.
This is why the European Commission and Member States agreed on an Action Plan
aiming at improving the control on the basis of existing legislation. It
focusses on four key areas: the functioning of notified bodies; market
surveillance; coordination in the fields of vigilance; communication and
transparency.
Main achievements under the
Joint Action Plan
The Plan has resulted in
substantial progress, in particular in the following areas:
-
Based on a Commission
Implementing Regulation (EU) No 920/2013 of 2013 clarifying the
criteria to be met by notified bodies, Member States
have re-assessed the qualifications and the scope of
activities of their notified bodies. This resulted in
corrective measures or limitations in the scope of activities of notified
bodies in 8 countries;
-
By May 2014,
voluntary joint audits of notified bodies by teams
involving auditors from several Member States and the Commission have been
carried out in 22 out of 23 countries having notified bodies. The last audit in
the remaining country has already been scheduled. The audits have resulted in
the identification of problems in the way notified bodies operated. Where major
shortcomings were identified, immediate corrective action was taken, including
temporarily suspending or limiting the scope of activities of the notified body
concerned. In one case, the notified body is no longer able to issue
certificates. Where necessary, a re-assessment of all certificates issued was
requested. For one notified body of the 689 certificates checked, 45 were
suspended and 18 withdrawn.. Under the new Commission Implementing Regulation,
such joint audits were made mandatory for new designations and re-designations
of notified bodies. 20-25 such audits are foreseen for 2014.
PIP highlighted the weaknesses
in vigilance which existed in the system. The Action Plan tightens up this
system by recommending that notified bodies shall carry
out unannounced audits of manufacturers. Notified
bodies have reported that they now are carrying out or are in the process of
launching such audits. However, no reliable information is available so far on
the number of unannounced audits or their effects.
Monthly vigilance
teleconferences with Member States, chaired by the Commission
services, now take place and are improving coordination between Member States.
More than 70 specific cases have been presented for coordination. In addition,
the Commission Joint Research Centre has started to analyse
trends on incidents.
The Commission Staff Working
Document discussed in the EPSCO Council contains a detailed analysis of these
elements as well as additional work arising from the action plan such as a
Commission Recommendation on the use of a specific system for traceability of
medical devices adopted in April 2013, ongoing discussion on improving product
registers, Member States reports on their market surveillance activities as
basis for further improvement, or discussions on incident reporting from
medical practitioners and patients.
The analysis shows that on
certain aspects of the Joint Action Plan progress has been limited and
continued work is necessary until the new
legislation comes into force. These aspects concern in
particular:
-
The organisation of unannounced
audits and their effectiveness;
-
Development of a common
understanding of market surveillance and better co-ordination and communication
on surveillance data;
-
Assessment of how to make best
use of registers for providing data and identifying problems on the long term
with devices;
-
Identification of mechanisms to
detect signals, trends and increased incident frequency more effectively based
on a JRC project to be presented mid 2014;
-
Assessment with Member States of
the need for, and possibilities of, organising peer training
programmes.
The implementation of the Joint
Plan has been a success. However, it is a series of short term measures
designed to maximise the potential of existing legislation. A long term
solution requires a thorough revision of the legal
framework. The adoption of the proposed new Regulations
is necessary to solve a number of outstanding issues. This relates in
particular to:
-
the scope of the
legislation,
-
the governance of the system and
its transparency,
-
certain obligations of notified
bodies, in particular in relation to mandatory unannounced
audits,
-
clinical
evaluation,
-
the risk classification of
devices and the safety and performance requirements,
-
the obligations of economic
operators,
-
the reporting of incidents by
users and patients to the Competent Authorities,
-
certain aspects relating to
vigilance system and market surveillance,
-
the role and the functioning of
the database Eudamed and the access of notified bodies to Eudamed,
and
-
the traceability of
devices.
Each of these points is pivotal
towards ensuring patient and consumer safety.
More
information:
http://ec.europa.eu/health/medical-devices/regulatory-framework/pip-actio
n-plan/index_en.htm