Doctrin receives MDR certification under class IIa
Doctrin announces that the company’s medical device, Doctrin Source, has received MDR certification under the EU Medical Device Regulation (EU) 2017/745, class IIa. The certification confirms that the product meets the high standards of safety, quality, and performance required for medical devices within the EU.
Doctrin previously held a CE-marked medical device in Class I under MDD 93/42/EEC, the former EU directive for medical devices. When this directive was replaced by the MDR in 2017/745, products previously certified under the MDD were required to undergo a new and more extensive certification process — a process that Doctrin has now successfully completed.
The MDR certification marks an important milestone in Doctrin’s continuous efforts to ensure quality and safety for both healthcare professionals and patients using the platform.
Tove Karlsson, Head of Product & Medical, PRRC at Doctrin says:
“The fact that Doctrin is now MDR-certified confirms that our processes and products meet the rigorous safety and quality requirements set by the EU for medical technology solutions. It is yet another confirmation that we are a partner that healthcare providers and patients can rely on when it comes to medical device safety and quality — now and in the future.”
Through the certification, the company’s product documentation and processes for design, development, risk management, clinical evaluation, and quality assurance have been thoroughly reviewed. The audit was carried out by the external notified body Intertek.
Anna-Karin Edstedt Bonamy, CEO of Doctrin says:
“We are very pleased to have obtained MDR certification in accordance with the EU Medical Device Regulation (EU) 2017/745. For us, it has always been self-evident that suppliers offering a service like Doctrin should be externally audited at this level. When it comes to patient safety, there should be no compromise. For Doctrin, this is not only proof of quality, it also strengthens our customers’ confidence and enables Doctrin to participate in more tenders and collaborations, both in Sweden and internationally.”
Doctrin will now begin the work of implementing and communicating the new certification in Doctrin’s product and channels.
About the EU Medical Device Regulation (EU) 2017/745
The EU Medical Device Regulation (MDR) is one of the world’s most comprehensive and stringent regulatory frameworks for medical devices. The regulation places high demands on manufacturers to meet clearly defined standards for safety, quality, and clinical performance. While Class I products require only self-assessment by the manufacturer, the significantly more comprehensive Class IIa requires the manufacturer to demonstrate compliance with a range of requirements before an external notified body. In this case, the assessment was carried out by the organization Intertek.
Media Contact:
Johanna Ahlberg
Head of Marketing and Communications
Doctrin
Phone: +46 72 539 97 51
Email: johanna.ahlberg@doctrin.se
