Unannounced audits of medical device manufacturers in EU are on the increase

According to the Commission the new measures have also improved the operations and effectiveness of notified bodies, which  are the organisations authorised by national governments to issue certificates stating that devices conform to the standards outlined in EU medical devices directives.

However the legal framework surrounding the manufacture of medical devices requires a "thorough revision" if a long-term safety solution is to be found, a statement by the Commission said.

Expert in medical device regulation Stuart Richards of Pinsent Masons, the law firm behind Out-Law.com, said: “Medical device companies in EU have long stressed that lax controls, lack of specialisation and poor oversight of notified bodies allowed scandals such as PIP to occur. While the introduction of unannounced audits on notified bodies and greater quality requirements may not itself avoid further scandals, it is to be welcomed as a step towards achieving the objective of the European Commission’s Joint Action Plan, restoring confidence in medical devices."

The Commission made its comments after the Employment, Social Policy and Consumer Affairs Council (EPSCO) discussed a Commission staff working document on the implementation so far of the Joint Action Plan for Immediate Actions.

The Joint Action Plan was introduced across the EU under the EU's existing medical devices legislation after it emerged that PIP "fraudulently made use of industrial silicone instead of the approved medical grade silicone in many of the breast implants manufactured," said the Commission. The fraud remained undetected until 2010 because no laboratory tests of implants were carried out and audits conducted by notified bodies were always pre-announced.  Investigations were triggered by what the Commission report described as "an unusually short-term breast implant rupture" and the product was withdrawn from the EU market. It is estimated that 400,000 women received PIP silicone breast implants worldwide, according to the Commission.

The Joint Action Plan aims at "bridging the gap" between existing legislation and tighter controls which it is proposed will be introduced with the adoption of further regulations relating to the sector, said the working document. The plan focused on the functioning of notified bodies, market surveillance, coordination in the fields of vigilance and the area of communication and transparency.

In relation to notified bodies, the document pointed out that although notified bodies were entitled to carry out unannounced audits at the time of the PIP case, "in most cases these audits did not take place."

Since the adoption in September 2013 of a Commission recommendation on the audits and assessments performed by notified bodies in the field of medical devices "the system of unannounced audits is gradually becoming more common," the document reported. By April 2014 more than 40 notified bodies "had, or were finalising, procedures and most were launching trials or had carried out real audits" which were unannounced. This followed a request from their national authorities to take into consideration on the recommendation on unannounced audits.

However a statement by the Commission issued alongside the document said that "no reliable information is available so far on the number of unannounced audits or their effects". The statement said that the issue of unannounced audits is among areas where "progress has been limited and continued work is necessary" until further legislation comes into force.

A main aim of the Joint Action Plan was to achieve "a uniform high standard for both the designation by the member states of the notified bodies and the functioning of these bodies," said the Commission.

The working document reported that after "nearly all countries" re-assessed the notified bodies dealing with high risk devices, there resulted "corrective measures or limitations in the scope of activities of notified bodies in at least eight of these countries". One notified body asked for the designation to be withdrawn.

A Commission statement said: "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."

The Joint Action Plan also introduced a pilot project of joint audits of notified bodies by teams made up of auditors of several member states and the Commission. By May 2014 the pilot had carried out audits in 20 member states. This found that all notified bodies assessed had non-conformities in their operations. This ranged from five to 20 non-conformities. In "about half the countries" the assessors found "major non-conformities", ranging from one non-conformity to six.

"To be able to keep their designation the notified bodies were obliged to undertake corrective actions with regard to the shortcomings identified and, in serious cases, a temporary suspension or limitation in the scope of activities sometimes combined with other actions such as re-assessments of all certificates issued by the notified bodies were imposed," the Commission's report said.

In one case a "complete de-designation" of the notified body followed, said the working document, and several other notified bodies stopped their activities without, or prior to, any joint assessment being announced.

In an attempt to further improve vigilance, member states now take part in monthly vigilance teleconferences. The working document reported that this is improving coordination between member states and that more than 70 specific cases have been presented for coordination. The Commission Joint Research Centre has also started to analyse trends on incidents.

In relation to market surveillance, the document reported that methods of market surveillance and resources designated to this varies widely between member states. As a result a device which is banned or restricted in one EU country may freely circulate in others.

Although the Commission described the implementation of the Joint Plan as "a success", its statement said: "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 Commission said that the adoption of the proposed new regulations is necessary to solve a number of outstanding issues including the scope of the legislation, the governance of the system and its transparency, the risk classification of devices and the safety and performance requirements and certain obligations of notified bodies, in particular in relation to mandatory unannounced audits.

Neven Mimica, EU commissioner for consumer policy, said:  “Consumers are safer today than they were when the PIP scandal was discovered.  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.”