It is now time to polish off the latest details, as May 26 is the deadline for application to the new rules. Let’s see some of the most frequently asked questions regarding the new regulation affecting medical devices.

A new regulation, but why?

The changes in demographic and the appearance of software as a medical device are two of the reasons why the Medical Devices Directive (MDD) needed an update. The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe and it is mandatory for all companies selling their products in Europe.

The MDR is focused on a life-cycle approach to medical device regulation. It encourages policies and procedures that elevate the responsibilities of medical device companies for their products throughout the lifecycle of the item.

What kind of medical devices does it apply to?

It is defined as an instrument, apparatus, appliance, software, implant, reagent, material or other article that is used for the following:

•    Diagnosis, prevention, monitoring, treatment or alleviation of disease, disability, or injury, but not for disability or injury prevention
•    Investigation, replacement, or modification of an anatomical, physiological, or pathological process
•    Providing data via in-vitro examination of samples derived from a human body

Will MDR affect CE markings and QMS?

The new regulations don’t seem to be having a significant effect on obtaining a CE marking. In regards to the quality management systems, manufacturers will need to establish, document and implement a quality system that is effective throughout the entire device lifecycle.

There will need to be documentation in the form of a quality manual and written procedures regarding the quality objectives, organization of the business, procedures for design control, quality assurance and verification procedures during manufacturing stage and other relevant tests and trials.