Meeting the new and stricter requirements, putting in place processes to meet the requirements and updating technical files requires knowledge, time and resources and of course the finances. Not all have the in-house capabilities/resources/funds so there is a risk of not being able to continue marketing the devices in the EU if they do not meet the requirements on time – Dr Tina Amini
In this first article in a four part series, New Medical Device Regulations (part 1), published on the 12th of February by BioStock, Dr Tina Amini shares her view on the changes and challenges that medical device manufacturers need to consider as soon as possible as well as highlighting the key dates to put in your calendar.
The new EU Medical Device Regulation (MDR) is a hot topic these days as the date for implementation is rapidly getting closer. After 26 May 2021, devices with valid MDD/AIMD certificates need to meet the new MDR requirements relating to post-market surveillance (PMS), market surveillance, vigilance, registration of economic operators and of devices.
The transition to MDR and IVDR will be challenging for all involved. Comprehensive work is required by all companies within the industry, Notified Bodies, and the European Commission. Still, many companies are not ready to meet the stricter requirements in time which may lead to them have to withdraw their medical devices from the market.
To provide deeper insights into the Medical Device Regulation (MDR), Dr Tina Amini has created a 5 part webinar based training series.
- Medical devices and their growing regulatory challenges
- New EU In vitro Diagnostics Regulation (IVDR) and Companion Diagnostics
- Are you ready for the new EU Medical Device Regulation?
- Session 1: Introduction to EU Medical Device Regulation (MDR) and key changes