Risk Manager
  • Solution
    • The Validated Approval Accelerator
      • Risk Management According to ISO 14971
      • Usability Engineering According to EN 62366
      • Essential Requirements According to MDR 2017/745 & IVDR 2017/746
      • Conformity Report for Medical Electrical Equipment According to EN 60601-1
      • Risk Management for IT Networks According to IEC 80001-1
      • Process Validation According to DIN EN ISO 13485
      • Clinical Evaluation According to MDR 2017/745 & MEDDEV 2.7.1
      • Software Lifecycle Process According to IEC 62304
    • References
      • What Our Customers Say – Success Stories
      • MST-Instrumente: Work and Time Savings
      • University Hospital rechts der Isar: Faultless Documentation and Achievement of the IEC 80001-1
      • Euroimmun: Cost Savings in Usability Engineering
      • biotrics bioimplants AG: Enrichment of the approval process by BAYOOSOFT Risk Manager
      • Selection from Our Customer List
      • Continuous Development since 1998 – Version History
  • Modules & Features
    • Modules
      • Risk Management
      • Usability Engineering
      • Essential Requirements
      • Medical Electrical Equipment
      • Machinery Directive
      • Requirements Engineering
      • Clinical Evaluation
      • Software Lifecycle Process
      • Medical IT Networks
      • REST API
      • Advanced Reporting
      • Pre-Validation Package
    • Features
      • Preliminary Hazard Analysis
      • Failure Mode and Effect Analysis
      • Structured Work According to Lifecycle Phase
      • Medical Device Classification
      • Post Market Surveillance
      • Self-Learning Knowledge Database
      • Fine-Grained Authorization Management
      • Visualizing with the Grey Box
  • Services
    • Services
      • Individual Services
      • Medical device classification
      • Software Validation – Your Service Options
      • License Model
      • System Requirements
      • Frequently Asked Questions
    • Contact
      • Upcomming Events
      • Test Now
      • Contact Request
  • Company
    • Company
      • About us
      • We think proactively
    • Our Partners
      • Get to know Our Partners
      • Become Partner now
  • Blog
  • Upcomming Events
  • Test Now
  • Customer Center
  • Search
  • Menu

Consequences for the medtech industry

No agreement between Switzerland and the EU

It has burst. The new agreement between Switzerland and the EU will not enter into force. After seven years of negotiations between representatives of the EU Commission and Switzerland, President Guy Parmelin declared the talks a failure yesterday. The reason, he said, was disagreement on crucial points of the negotiations, such as access to the EU’s internal market and agreements on the free movement of persons. The modernisation of the agreement, which has been in place since 1972, has thus failed to materialise.

A failure that particularly affects the Swiss medtech sector shortly after the transition to the new MDR 2017/745. What does this mean for access to the EU internal market?

Due to the loss of privileged access, Switzerland will now be downgraded to the status of a third country. Manufacturers must therefore adapt when placing new medical devices on the European market.

The consequences are additional work due to increased requirements and having to go through the European approval process. In addition to the designation of a specific Notified Body, the preparation of corresponding technical documentation is also required.

As a Swiss company, are you affected by the collapsed framework agreement?

Contact us. We have developed a system with which you can create a CE-compliant variant from your existing technical documentation. With the help of the validated software solution, you can implement this independently and make a new product file for a class IIb medical device ready for documentation within six weeks. Guaranteed – because we assure you of the compliance of the technical documentation.

In this way, you efficiently accelerate the approval of your medical device despite the new situation.

Do you have a question? Contact us!

We look forward to hearing from you.

Our Succes Story

How we were able to help MST-Instrumente GmbH save labour and time in processing according to IEC 60601-1? Read more about our shared history here:

Would you like to get to know the validated approval accelerator directly free of charge? Sign up for a 30-day TRIAL.

Test now for free

News

  • Disabled female use prosthesis of hand, artificial limb, closeup. Disability, high tech medical careClassify medical devices and IVD correctly10. May 2023 - 14:49
  • Now available: Themis Documentation Guide4. April 2023 - 19:04
  • IEC 80001-1 Risikomanagement und KRITIS Risiko Critis RiskmanagementAre you sure that your CRITIS is secure?15. March 2023 - 14:04
Contacts at BAYOOSOFT 

Svenja Winkler
CEO
[email protected]

 

 

Franziska Weiß
Head of Sales [email protected]

Darmstadt
Lise-Meitner-Straße 10
64293 Darmstadt

Munich
Aidenbachstraße 54
81379 München

Berlin 
Mariendorfer Damm 1-3
12099 Berlin

Phone: +49 (0) 6151 – 86 18 – 0
Fax: +49 (0) 6151 – 86 18 – 150

Contact: [email protected]
Support: [email protected]
Jobs: [email protected]
Press: [email protected]

  • Privacy Policy
  • Legal
BAYOOSOFT @DMEA 2021 BAYOOSOFT Risk Manager @T4M
Scroll to top