MENU menu

Top 3 Changes in the EU MDR


Happening Now,


From 26th May 2021 the new EU Medical Device Regulation (MDR) will be in full force. For a long time, Medical Devices and their regulations have proven to be restraints for new market entry.


Here are the top 3 Changes which are coming into effect from 26th May 2021 under the new MDR


Person Responsible for Regulatory Compliance (PRRC) is an entirely new role which the MDR and IVDR have introduced.

The PRRC is responsible for ensuring the manufacturer's compliance with the regulations. This person should be the organisation's employee, but services can also be outsourced but only if a micro or small enterprise. The PRRC should be permanently and continuously at the company's disposal.


Rule 11 of the Medical Device Regulation (MDR) will push most Software as a Medical Device (SaMD) from the lowest risk classification (Class I) into the higher risk classes (Class IIa/b or III).  

This means that manufacturers of SaMD will move from a self-notification process to having to engage a Notified Body resulting in more regulatory compliance activities, additional resource required to ensure compliance and a significant increase in financial costs.


The MDR places much greater emphasis on monitoring the performance of CE-marked medical devices, i.e. post-market surveillance (PMS). PMS is required regardless of the medical device classification, but requirements will vary because it will be proportionate to the risk classification.


The new regulations can be challenging to navigate. Feel free to contact our Experts for a Free consultation and get answers to all your regulatory needs. At Med-Di-Dia, we ensure complete compliance with the regulations by providing full-time support to our clients.

Call Now +353 (0)91-704804

Send An Email




Get access to the Med-Di-Dia’s newsletter, where industry experts help you to stay on top of shifting global markets.

Stay updated with the latest Trends in the world of Medical Devices!


* indicates required