We are proud to announce that Pharmia Oy is an EU MDR 2017/745 certified manufacturer. The certificate will come into effect on 01.12.2022 and was granted by Eurofins Electric & Electronics Finland Oy (NB number: 0537). The certificate is for device category: MDN 1213 Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route and covers already 23 products in MDR risk class IIa.
This certification is key to Pharmia’s success and progression in the field of CE-marked medical devices. This certification also represents our mission: “We lead the way – our expertise encourages customers towards responsibility”. We are especially delighted that we have got the opportunity to be among first companies to receive this certification in Finland, and in the field of MDR-approved substance-based nasal sprays we are even one of the first companies in the European Union to earn this acceptance.
Our focus during year 2023 will be to add all existing Pharmia’s MDD devices to MDR and our goal is to success with this before transition period ends in 26.5.2024.
We want to thank all of our customers for helping us – your encouraging attitude and words during the process meant a lot to us. Special thanks also to our Notified Body and our external clinical evaluators.
Pharmia Oy
Medical Device team
We are happy to provide more information:
Maria Myllyniemi, Productization Manager, PRRC, maria.myllyniemi@pharmia.fi
Anu Ahokas, R&D Specialist, anu.ahokas@pharmia.fi
Elina Antila, R&D Engineer, elina.antila@pharmia.fi
