New Swissmedic Class 1 MDR Device Labeling Requirements
The Swissmedic guidance mandates the inclusion of CH-REP (Swiss Responsible Person) information on the labels of Class…
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PMPF Under the IVDR: Methods, Justifications, and Triggers
As we have mentioned in…
What is the Difference Between PMS and PMPF Under the IVDR?
While post-market clinical follow-up (PMCF) studies were a concept…
Linking IVDR Performance Evaluations and Risk Management
Similar to…
MDD Declaration of Conformity After 26 May 2021
As a regulatory representative for foreign manufacturers in the EU, UK, US, and Switzerland, MedEnvoy participated in several audits with…
Performance Evaluation Reports Under the IVDR
The performance evaluation report (PER) is the culmination of the application of the performance evaluation process to a specific IVD…
Ensuring Compliance for Foreign Manufacturers of CE Marked ‘Legacy Devices’: Common Pitfalls and Solutions
As a regulatory representative for foreign manufacturers including those who are CE marked ‘legacy device’ in the EU, Switzerland and…
Swissmedic Audit Reveals Compliance Issues with Class I Medical Device Manufacturers
Swissmedic, as expected, has started auditing and inspecting relevant economic operators. For example, Swiss-authorized representatives were subject to systematic…
The Relevance of Device Stability Studies to IVDR Performance Evaluation
Under the IVDR, the performance evaluation report (PER) is supported by three “sub-reports” comprising the scientific validity report (SVR),…
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