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  • MDSS News & Events

    MDSS News & Views

Warning - For risk class I devices!

Products, which stay class I under the MDR, must be in full compliance by May 26 2020!



  1. MDSS concern: Some clients seem to be under the impression that there was an extension given until May 2024 due to the MDR second corrigendum. This is not true.


  2. MDSS concern: Clients who have class I devices and higher risk class devices were also under the impression that their risk class I devices are also covered by the EC certificate for the higher risk class devices. This is not true. Please check in particular the accessories.


  3. MDSS concern: Clients who mainly have In Vitro Diagnostic Medical Devices, were under the impression that their medical devices as well fall under the application date of the IVD Regulation. This is not true.



Conclusion: All risk class I devices (MDD/MDR) must comply by May 26. 2020!

This means the EC REP contract must be fully executed and the EC REP must have performed the tasks outlined in the Mandate for the risk class I devices by May 26. 2020! Otherwise the products cannot be sold in Europe.

Categories: news

For risk class I manufacturer!

Warning: No additional  transition for risk class I products.  Products who are risk class I and stay of risk class I must fully comply to the MDR by May 2020.

Please consider the MDCG guidance Guidance Notes for Manufacturers of Class I Medical Devices cover.pdf - December 2019. It was recently published and is great outline of what needs to be done specifically for risk class I products (see also News & Views 2019.12.19). We guess we can call this THE EIGHT STEPS TO CLASS I CE MARK.



Indeed it does extract the important aspects and should get you in compliance quickly.

Categories: News

MDR deadline for risk class I Manufacturers – Ready to appoint MDSS as your MDR EC REP?

The MDR deadline for Manufacturers of risk class I products is approaching. The days until May 26, 2020 are numbered!


It is fundamental that class I Manufacturers prioritize their MDR compliance in order to ensure a smooth transition to the MDR and avoid any market disruption by May 2020.


The transition period has started in 2017. Manufacturers must update the declaration of conformity to reflect the compliance to the MDR. This does not include only an update of the technical documentation but also the requirements of Article 10 to meet the new MDR requirements.


CONTACT NOW your MDSS team to get your products ready to market by May 2020!!!


The existing MDD Authorized Representative contract will no longer be sufficient for the transition to the new regulation. The appointment of the Authorized Representative under the MDR is a mandatory requirement to achieve compliance by May 26, 2020. In order to act as your EC REP, the regulation requires that the Manufacturer provides an official Mandate to the EC REP.  Such a mandate shall be in writing and agreed by the EC REP.  The mandate shall contain a minimum set of tasks.  The new MDSS MDR EC REP contract is the basis for such a mandate. Clients should submit their MDR transition plans and consider MDSS resources to perform the tasks required under the MDR mandate.


MDSS has implemented a special plan for its clients.  Any remuneration fees still not used on the MDD contract will apply to the MDR Mandate.


Please contact your Account Administrator at MDSS!

Categories: News

IMPORTANT, Important … Guidance for class I manufacturer!

MDCG 2019-15 - Guidance Notes for manufacturers of class I Medical Devices was published last Tuesday, the 17th of December.

And other guidance have been published which are also important.


You may monitor with your quality system this website of the European Union.  It seems that all guidance’s are being published here first. The docsroom.


Most certainly the overall EU website for medical devices provides further information:
Here you may subscribe to newsletter to be informed of changes.  It is our impression that it does not always work or you receive a newsletter rather late.

Categories: News
MDSS GmbH

Schiffgraben 41
30175 Hannover
Germany

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