Top 3 Changes in the EU MDR
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
1. Need for PRRC
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.
2. Reclassification of SaMD
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.
3. Increased Post Market Responsibilities
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.
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