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End of CE Marking on Unimed Articles

Dear clients,

In 1980, Unimed started a subcontracting activity in parallel to its main activity as a manufacturer of needles and medical devices.

Over the past 40 years, we have seen the growth and increasing proportion of our subcontracting activity overtake and then largely supplant our activity as a medical device manufacturer. More recently, this manufacturing activity has become marginal as a proportion of our subcontracting activity, and by 2020 it accounts for only a small portion of our business.

At the same time, we have also seen over the past 40 years that the regulatory requirements to obtain CE marking on medical devices in order to sell products on the market as a manufacturer have become increasingly administrative and disconnected from all forms of pragmatism and this without enhancing product quality or safety for patients and users, which was and should have remained the primary goal of regulation.

In the years to come, several new heavy regulations will further burden the regulatory system. New medical device regulations soberly entitled MDR/IVDR will supersede MDD 93/42/EEC following an initial deferral to 2021, and the unique device identification (UDI) imposes many other requirements to be met.

In order to focus as much as possible on the subcontracting service offered to our manufacturing customers, Unimed has taken the heavy decision to stop obtaining the CE mark on its own products intended for human medicine and to become a company acting exclusively as subcontractor, which we had become de facto in 40 years of reconversion. This will allow us to reduce our regulatory burden and allocate our quality assurance team to serve our manufacturing customers, rather than defending our own products.

This change will come into effect on 31.10.2020 and from this date no Unimed articles will be supplied with CE mark.

Our commercial department stays at your disposal to explain to you the concrete implications on the standard "Unimed" products for human medicine that you used to order and what solutions are available to you.


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COVID-19

Dear customers,

In the light of the recent covid19 pandemic and the measures taken by national governments to counter it, impacts on our production lead times are now more and more likely to occur. Our commercial department will keep you informed of the corresponding reports. We thank you for your understanding.



Summer Closing

Please note that our production will be closed during our yearly summer break from July17th until August 10. Our offices remain open during this period and we stay at your disposal for any enquiry or demand. We wish you already to have a great summer.



Winter closing 2019

We would like to inform our esteemed clientele that our production will be closed for our winter break from December 23rd 2019 until January 5th 2020. Our commercial department will stay at your disposal for any enquiry or questions. We wish you already our warmest season's greetings. 


[Translate to en:] Unimed Suisse

Summer Closing

Please note that our production will be closed during our yearly summer break from July12 until August 5th. Our offices remain open during this period and we stay at your disposal for any enquiry or demand. We wish you already to have a great summer.



ISO 13485:2016

We have the pleasure to inform you of the renewal of our ISO 13785:2016 certificate. It is now available from our download page.



CE Certificate

We have the pleasure to inform you of the renewal of our CE Certificate. It is now available from our download page.



List of our standards stainless steel tubes and wires

We inform you that our current list of standard dimensions stainless steel tubes and wires has been updated. The new version is now available on the corresponding page of our internet website. In addition to those standard dimensions stainless steel tubings, we may produce special tubings based on your required dimensions. Do not hesitate to contact us should you have any request for quotation related to it.



Winter closing 2018

We would like to inform our esteemed clientele that our production will be closed for our winter break from December 24th 2018 until January 2nd 2019. Our commercial department will stay at your disposal for any enquiry or questions. We wish you already our warmest season's greetings. 



ISO 9001:2015

We have the pleasure to inform you of the renewal of our ISO 9001:2015 certificate until december 2021. It is now available from our download page.