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Pharmaceutical & Medical Packaging News, May/June 2015

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Viewpoint • Pharmaceutical & Medical Packaging News May/June 2015 18 Unannounced Audits: First Refections Packaging, sterilization, and assembling are among the critical processes that could be evaluated. By Peter Drechsler, Team Leader, Unannounced Audits, BSI Germany; Gert Bos, Head of Regulatory and Clinical Affairs, BSI Healthcare; and Paul Sim, Regulatory Affairs Manger, BSI I n February 2012, the European Health and Consumer Policy Com- missioner John Dallí "called on Member States for immediate action to be taken at national level to ensure full and stringent implementation of the current legislation on medical devices. Following the discovery of the fraudulent use of non-medical grade silicone in breast implants manufac- tured by the Poly Implant Prothèse (PIP) Company in France, the priority now is for the Member States and the Commission to act together to tighten controls, provide a better guarantee of the safety of medical devices and to restore patient confidence in the law that protects them." ¹ EU Health ministers were asked for immediate actions to restore public confidence in the European legislative system. The Joint Plan for Immedi- ate Actions under the existing medical device legislation was introduced to the public in February 2012. The plan proposed to the Member States joint actions aimed at tightening controls on medical devices in the framework of the current legislation. The plan focused on four pillars: functioning of notified bodies, market surveillance, coordination of corrective actions among the Member States following vigilance and market surveillance, and communication and transparency. One key aspect of the Joint Plan for Immediate Actions was to enforce all notified bodies to make full use of the powers given to them under the cur- rent directives. In particular, these powers include unannounced audits on the premises of the legal manufactures of medical devices. A recommenda- tion aimed at the Member States was conceived to provide advice on the arrangements needed for facilitating these audits by notified bodies. ² LEGAL SITUATION The legal basis for conducting unannounced audits was laid down in the first issue of the Council Direc- tive 93/42/EEC of 14 June 1993 concerning medical devices. Annex II 5.4 allows Notified Bodies to perform unannounced audits: "In addition, the notified body may pay unannounced visits to the manufacturer. At the time of such visits, the notified body may, where necessary, carry out or ask for tests in order to check that the quality system is working properly (…)". ³ T h e s a m e a p p l i e s f o r c o n f o r - mity assessment routes according to Annex V and VI. Similar provisions can be found in the Council Direc- tive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (Annex II and V) ⁴ and in the Directive 98/79/ EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (Annex IV). ⁵ Although entitled to carry out unan- nounced audits, in most cases Notified Bodies did not use this instrument to routinely survey the manufacturers of medical devices prior to the PIP scan- dal, unless it would be a "for-cause" inspection. ⁶ The members of Team-NB, which include approximately 40% of all Notified Bodies, so representing the vast majority of EC certificates issued, committed themselves to follow the recommendation of the European Commission, as stated in the Team- NB code of conduct. ⁷ The recommendation is directed at the Member States of the European Community, and Member States may introduce it to its legislation. Even without legal weight, the recommen- dation for unannounced audits can- not be ignored by the Member States, given its great political weight. Com- petent Authorities need to show that they are willing to protect the health of their citizens after the recent scan- dals in the medical device healthcare industry. Therefore, Notified Bodies are enforced to perform unannounced Even without legal weight, the recommendation for unannounced audits cannot be ignored by the Member States, given its great political weight.

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