Swissmedic Annual Report 2018

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62 Market access | Medical devices European market surveillance activities Since Switzerland is integrated into the European medical devices system, it carries out market surveillance activities in consultation with partner authorities from contracting states in addition to its national market surveillance activities. Activities • The number of requests for mutual assistance from European partner authorities rose from 144 to 180. • The number of requests made by Swissmedic to European partners remained stable at 32. • As part of efforts to step up surveillance of CABs and accredit them under the new European Regulations (MDR/IVDR), Swissmedic once again took part in internationally accompanied audits of CABs during 2018. Materiovigilance Activities • A total of 2,488 incidents were reported in Switzerland, a further sharp increase of 36 % on the previous year’s figure. • The implementation of corrective safety measures in Switzerland was monitored in 676 cases. A total of 72 reports on defective medical devices (National Competent Authority Reports, NCARs) were prepared for distribution to foreign authorities, while Swissmedic received 845 NCARs from its European partner authorities. • In 634 cases, a public safety report was published on the Swissmedic website for the information of users. • In 2018, Swissmedic again discussed new suspected incidents and concrete action on pending cases during monthly telephone conferences with the other European surveillance authorities. • With Swissmedic’s active participation, the new Manufacturer’s Incident Report (MIR) form was drawn up, approved and introduced throughout Europe. Manufacturers and users have an obligation to inform Swissmedic of adverse events that take place in Switzerland. Companies must also inform Swissmedic of measures they have taken, such as product recalls, which the Agency then monitors. Swissmedic is integrated within the European reporting system and also informs affected contracting states about incidents and measures taken in Switzerland. 2018 72 2017 77 845 870 1850 2488 2987 3650 2016 98 850 1605 2836 Incidents; number of reports from Switzerland Incidents; number of reports overall: materiovigilance cases opened NCARs received NCARs issued
Market access | Medical devices 63 Market monitoring Efficient state-organised controls are essential in guaranteeing a high level of patient safety. Distributors of medical devices in Switzerland must guarantee the conformity of their products. Swissmedic receives suspicion reports, initiates the necessary corrective measures and monitors implementation. The Agency works closely with the cantonal authorities in this area. Activities • Swissmedic received a total of 205 reports of suspected non-compliant medical devices. In view of the persistently high number of reports, processing is based strictly on the potential risk involved. • Swissmedic imposed corrective measures on market participants in Switzerland in 87 cases. 2018 205 * 87 * 219 * Clinical investigations Swissmedic approves and monitors clinical investigations of medical devices for human use if the products or intended uses are not yet CE certified. Approval has been mandatory for this type of investigation since 1 January 2014. While the investigations are in progress, Swissmedic monitors incidents subject to a mandatory reporting requirement, such as serious events and reports on participant safety. Swissmedic can inspect investigators, sponsors and research institutions throughout Switzerland, and records notifications and measures from the country in EUDAMED. Furthermore, the Agency helps draft international guidelines and design training events for the purpose of enhancing implementation. Activities • 36 applications for new trials involving non-CE-marked medical devices were submitted. • 85 applications for variations were received. • One clinical trial in progress was inspected. • The option of submitting documents for clinical trials of medical devices online via the Swissmedic Portal was introduced in autumn 2018. 2017 153 273 385 2016 135 275 342 Reports received Corrective measures Procedures completed * compiled using new recording methods; figures not comparable with the two preceding years.
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Annual Report 2018
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3 Contents Foreword by Stéphane Ro
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5 Standards Legal framework Legisla
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7 Raimund Bruhin, director “Not t
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9 The situation subsequently calmed
Page 11 and 12: 11 Basis for development cooperatio
Page 13 and 14: 13 Better protection against defect
Page 15 and 16: 15 undercover investigations in one
Page 17 and 18: 17 Autologous transplant products T
Page 19 and 20: 19 Temporary authorisation: rapid a
Page 21 and 22: 21 Number of authorisations by disp
Page 23 and 24: Market access | Marketing authorisa
Page 35 and 36: 35 Variations requiring approval an
Page 39 and 40: Market access | Licensing 39 Licens
Page 41 and 42: Market access | Licensing 41 Clinic
Page 43 and 44: Market access l Inspections 43 Insp
Page 45 and 46: Market access l Inspections 45 GLP
Page 47 and 48: Market access | Licensing 47 Licens
Page 49 and 50: Market access | Licensing 49 Analys
Page 51 and 52: Market access | Medicinal products
Page 61: Market access | Medical devices 61
Page 65 and 66: Market access | Medical devices 65
Page 67 and 68: Standards 67 Standards Legal framew
Page 69 and 70: Standards 69 Pharmacopoeia The phar
Page 71 and 72: Penal law 71 Investigative measures
Page 73 and 74: Penal law 73 Decisions / verdicts b
Page 75 and 76: Stakeholder management 75 Press rel
Page 77 and 78: Stakeholder management 77 Events Sw
Page 79 and 80: Stakeholder management 79 Collabora
Page 81 and 82: Stakeholder management 81 • Swiss
Page 83 and 84: Stakeholder management 83 Special a
Page 85 and 86: Information technology and telecomm
Page 87 and 88: Corporate Governance 87 Agency Coun
Page 89 and 90: Corporate Governance 89 Chair Stép
Page 91 and 92: 91 Remuneration Remuneration for th
Page 93 and 94: Organisation 93 Members of the Vete
Page 95 and 96: Organisation 95 Nicole, Messi Mara,
Page 97 and 98: Balance sheet 97 Balance sheet (in
Page 99 and 100: Erfolgsrechnung 99
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Swissmedic Annual Report 2018

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