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10 things you didn’t know about MDR

 

 

 

 

1

The word ”safety” appears 290 times in the MDR. The MDD, by comparison, uses it only 40 times.

2

The new regulation is four times longer, and contains five more annexes than its predecessor, the Medical Device Directive (MDD).

 

 

 

 

 

3

Companies undergoing transition will need to revisit core processes including the quality assurance, risk management, and postmarket expectations. These will require careful review, planning and updating to re-implement in compliance with the new requirements.

4

The definition of Medical Device will be broadened to include non-medical and cosmetic devices not previously regulated. Examples include products for cleaning, disinfection or sterilization of devices as well as contact lenses, liposuction equipment, or epilation lasers.



 



5

The new rules will require most companies to update clinical data, technical documentation, and labeling.

6

Manufacturers will need to generate and provide more in-depth clinical data to prove safety and performance claims.

 



 

 

7

Manufacturers will need to report all incidents, injuries and deaths into an EU portal that will centralize relevant data so that patients have access to more safety-related information. Reporting for incidents that did not result in death or serious deterioration in health is moved to 15 days from 30 days.

8

Reclassification of many Medical Devices to a higher risk class and a new classification for reusable surgical devices requiring notified body oversight.

 

 

 

 

 

9

IVDs are now classified into four risk classes that will require notified body review for about 90% of the devices, up from the current 10%.

10

Class I full QMS covering all areas.

 

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