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SGS Fimko Oy has been designated as a notified body according to MDR (EU) 2017/745. The designation was long-awaited endpoint after years of tough assessment process, performed by multinational authorities. The designation, together with the designated scope, was published in the EU NANDO register on 9 January 2021.

Notified body manager Seppo Vahasalo states that “It was a demanding process to create a notified body quality system that meets the requirements of the new legislation and to demonstrate the system to the authorities. We were able to comply, as expected. The designation means that we can continue to assess the higher risk class medical devices and to issue EC certificates as proof of compliance.”

SGS Fimko has a long and wide experience in testing the electromedical devices. This means that also the notified body focus is active medical devices, including software. This is indicated in the designated scope given in the NANDO register.

Lack of resources in medical devices regulatory issues

All medical device manufacturers have a common problem. Even while the Date of Application for the new legislation was postponed for one year, there are not enough MDR notified bodies in the Europe. Because the new legislation requires more extensive assessment, less devices can be assessed with existing resources.

“We have continuously increased our notified body resources and have created an outstanding team. Despite of that, we know that there are bottlenecks, especially when qualifying new people to assess quality management systems and devices is a long and demanding process. We are seeking new competent people and you are welcome to contact me”, encourages Vahasalo.

All new medical devices and all manufacturers must comply with the new requirements starting from 26 May 2021

Starting from May, the new Medical Devices Regulation (EU) 2017/745 will fully replace the old legislation, based on the Medical Devices Directive. It means that starting from 26 May 2021 it is not possible to place on the market in EU new medical devices that do not comply with the new legislation. Equally all medical device manufacturers, independent on risk class, must comply with regulations regarding for example quality system and post-market follow-up.

For the devices placed on market based on directives there are transition rules in the MDR. Depending on the route that has been used in placing on the market, the transition period can continue until the last date of validity of the EC certificate or up to maximum of 26 May 2025.

Additional information:

Seppo Vahasalo
Notified Body Manager
mob. +358 40 560 9500