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.