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Pharmaceutical & Medical Packaging News, May/June 2015

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Viewpoint • Pharmaceutical & Medical Packaging News May/June 2015 22 consequence of suspension or cancella- tion of those certificates. SUMMARY Regular unannounced audits have placed additional obligations on both the Legal Manufacturer and the European Notified Bodies; this article explains some of the detail contained within the EU Recommendation 2013/473/EU. Following discussions with the UK Designating Author- ity (MHRA), German Designating Authority (ZLG), and a number of other Notified Bodies, BSI agreed an implementation date of the April 1, 2014. Since that date we have been conducting unannounced audits of our manufacturers holding EC Certificates in diferent countries. Predominantly the legal manufacturer has been the subject of the audit; we have, how- ever, conducted a small number of unannounced audits at critical sub- contractors or crucial suppliers. As the program develops in the future, it is likely that more critical subcontractors or crucial suppliers will be visited. To help organizations certified by BSI understand the recommendation and to encourage audit preparations, we sent a number of communications and delivered publicly available webi- nars (http://medicaldevices.bsigroup. c o m / e n - G B / o u r - s e r v i c e s / U n a n - nounced-audits-from-BSI/). Sub- sequently, our QMS Assessors and Technical Experts were trained in the requirements of the Recommendation and the requisite processes and proce- dures in order to allow them to con- duct the audits. Our experience to date has been very positive—we have found that manufacturers are aware of the rec- ommendation and the requirements and have or are implementing proce- dures for managing the audit. Unlike routine surveillance audits, no prior notification is given; the first point at which the auditee is aware of the audit is when our team presents itself on site. Some practical issues are emerg- ing, including, for example, how to access restricted or secure sites; how to handle arrival on site undergoing another audit in process, such as by U.S. FDA; the importance of clients notifying us when not manufacturing; and how to manage the issue around "multiple" audits, etc. These and other issues require further harmonization between Notified Bodies and other stakeholders to find suitable and prag- matic approaches. It is fair to recognize one criti- cism particularly from the smaller or medium-sized organizations: that of the costs associated with unannounced audits, not only the Notified Body fee, but also the need, ability, and resources to be able to support the on-site audit along with the issue of a potentially disproportionate audit duration to the size of company where a limited range of devices are pro- duced. For example, a two-person company manufacturing one device still is subject to a minimum audit of one day by two people. Therefore, as we go forward, some of these subjects will undoubtedly be reviewed and discussed with our UK and German Designating Authorities in conjunction with other Notified Bodies, as well as with Team NB to further detail their Code of Conduct on the issues relating to the unannounced visits. ⁷ REFERENCES 1. EC - Press Release. Medical devices: European Commission calls for immediate actions - tighten con- trols, increase surveillance, restore con- fidence. [Online] 2012. [Cited: 11 01 2015.] release_IP-12-119_en.htm?locale=en. 2. EC. COMMISSION STAFF WORKING DOCUMENT: Imple- mentation of the Joint Plan for Imme- diate Actions under the existing Medical Devices legislation. [Online] 2014. [Cited: 11 01 2015.] http:// files/swd_pip_14_en.pdf. 3 . C O U N C I L D I R E C T I V E 93/42/EEC of 14 June 1993 concern- ing medical devices. OJ. 1993, Vol. L 169, p. 1. 4 . C O U N C I L D I R E C T I V E 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices . OJ. 1990. Vol. L 189, p. 17. 5. Directive 98/79/EC of the Euro- pean Parliament and of the Council of 27 October 1998 on in vitro diagnostic med- ical devices. OJ. 1998. Vol. L 331, p. 1. 6. EC. SWD(2014) 195 final: COM- M I S S I O N S T A F F W O R K I N G DOCUMENT -- Implementation of the Joint Plan for Immediate Actions under the existing Medical Devices legislation. [Online] 2014. [Cited: 05 01 2015.] medical-devices/files/swd_pip_14_ en.pdf. 7. Code of Conduct for Notified Bodies under Directives 90/385/EEC, 93/42/EEC and 98/79/EC (V3.3). [Online] 2015. [Cited: 30 01 2015.] http://www. ofConductMedicalNotifiedbodiesv3- 3dd14-1-2015.pdf. 8. COMMISSION RECOMMEN- DATION of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices. OJ. 2013, Vol. L 253, p. 27. 9. Notified Bodies Recommenda- tion Group. "Testing during unan- nounced Audits" V2.3. [Online] 2014. [Cited: 15 01 2015.] http:// N B R G % 2 0 W G % 2 0 T e s t i n g _ U A _ Interim_NBMed_Consensus_Ver- sion_140812_2_3.pdf. 0 Our experience to date has been very positive— we have found that manufacturers are aware of the recommendation and the requirements.

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