Key aspects of the new Medical Device Regulation (MDR)

Key aspects of the new Medical Device Regulation (MDR) What is the aim of the new Medical Device Regulation (MDR)?

The purpose of the new MDR is to extend safety and potency within the EU medical device market.

The predecessors of the MDR; the Active Implantable Medical Devices Directive (AIMDD) and also the Medical Devices Directive (MDD), that were introduced within the early 90s, served their purpose for a protracted time and helped produce the marketplace for medical devices in Europe.

Now both old MDD and AI MDD merged into one document MDR However, medical device Contract Development and producing Organizations (CDMO) disclosed some weakness within the implementation of those directives. in conjunction with scientific and technical developments, an amendment in legislation was needed.

Placing medical devices on the ecu market could be an advanced method and understanding new legislations are often tough. The new revised MDD called MDR have many vital changes. Here is a number of the key aspects still as however Iziel health care can support and help in preparing new documentation changes required for satisfying the new regulation.

Salient points are as below 1. The application date for the new MDR is set for May 2020. This date is already passed but fortunately European Parliament adopted European commission’s proposal on extension of this date by one year. So new date now is 26th May 2021. Manufacturer should take advantage of this new extension and make their PMS (Post market surveillance) and PCMF (Post Market Clinical follow-up) and related clinical requirement.

2. Longer time for placing a product on the medical device market 3. Higher pressure on Notified Bodies and Competent Authorities as to do lot of work of their clients in limited time.

4. All medical devices need to be re-assessed for compliance and certification this also involves reclassification.

5. Compensation for damage caused by defective medical devices- This is very defined aspect which can impact business perspective if actions are not based on risk assessment.

Manufacturer or dealing in Medical device business must consider this transition very seriously and use external available external expert consultancy support like Iziel-Healthcare.