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MDR / IVD Swiss Implementation Task Force
Swiss Medtech prepares for EU regulations
The implementation of the two EU regulations for medical devices (MDR) and in vitro diagnostics (IVDR) presents major challenges for the Swiss medical technology industry. Swiss Medtech's MDR / IVDR Swiss Implementation Taskforce (SIT) provides companies with a comprehensive exchange platform. Under the motto «From the Industry - For the Industry» sector representatives support each other in the timely fulfilment of the complex conditions. Coordinated by Peter Studer, Senior Expert Regulation, the programme includes discussion forums, information services, and conferences. Further solutions and strategies will be developed together with experienced specialists.

Through its new regulations, the EU wants to ensure better protection of patient health and safety. This, however, means additional and broader requirements for the entire medtech industry: from manufacturers and dealers, to Notified Bodies and competent authorities, to doctors and hospitals. All parties are affected by the regulatory changes.

Significant changes, much uncertainty

The fulfilment of the MDR and IVDR requirements (with general transition periods of three and five years, respectively) is also associated with extreme effort, high costs - as well as many other unanswered questions affecting the medtech industry in Switzerland. Companies must, among other things, review and adjust entire product portfolio, re-organize clinical assessment and technical documentation, modify logistics and IT systems, and allocate resources and financing for the implementation. Early preparation and initiation of necessary steps will be decisive to ensure success and, for the smaller SMEs, may even be vital.

Active participation of industry representatives

SIT is a Swiss Medtech task force which enables domestic industry representatives to support each other in the introduction of MDR and IVDR. Swiss medtech companies can actively participate in this informational and exchange platform in order to prepare for the new regulations and applicable Swiss legislation. SIT currently provides information on the effects, problems, ambiguities; as well as official regulatory work via the website, newsletters, and direct inquiries. Various thematic forums will provide opportunity to discuss new insights, potential obstacles, as well as transitional provisions.

 

Specialist Discussion Groups

These discussion forums or groups are moderated by experienced industrial representatives (RA, process, and product specialists). Future-oriented innovations will be discussed in connection with the following industry-relevant topics :

  1. Notified Bodies and Conformity Assessment(N)
  2. Regulations and Environment (R)
  3. Clinical Data and Innovation (K)
  4. Industry Players and Databases (W)
  5. Quality Management Systems (Q)

 

Useful practical approaches and creative solutions will be developed in the SIT discussion groups regarding, for example, product registration, clinical data, the application of classification rules, and the issuing of new certifications.

  • The discussion groups are open to all medtech companies. Members of the following Swiss associations: Swiss Medtech, the Diagnostics and Diagnostic Devices Industry (SVDI), the Institute for Practice-oriented Qualification (IPQ) and the Swiss Association for Quality, Medical Products Specialist Group (SAQ) may participate free of charge. For further details, please see the application forms.

 

A bridge to the authorities

Thanks to its active collaboration with the authorities, SIT is also in a position to send any open questions, points of contention and necessary clarifications directly to the national competent authorities; and thus also to the EU Commission. As a result, SIT concerns receive the appropriate attention and priority  required. Conversely, SIT can also demonstrate to what extent the results of the European «CAMD Implementation Taskforce» affect Swiss business.

  • The SIT activities are coordinated by Peter Studer, Senior Expert Regulation; formerly of Swissmedic.
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Participation fee

Per event: CHF 290.-

Free of charge for Swiss Medtech, SVDI, IPQ and SAQ medical products specialist group members

Upcoming SIT Discussion Group events

QMS

Programm: DGQP3
Datum: 22. August 2018
Zeit: 09:00-12:30
Ort: Brugg


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