Don’t procrastinate due to the EU MDR Transition extension : Results may be Costlier

Extension of EU MDR Transition

The recent announcement of the EU MDR transition extension need not make you to procrastinate the actions to be taken to be EU MDR compliant as soon as possible if you wish to gain competitive advantage and enhanced market share in future. 

It is widely accepted fact that, delivering “preferred product” to the consumer can help you to sustain competitive edge in the market. “EU MDR compliant product” can be that “preferred product” in coming years.  

Proposal for MDR transition extension is definitely a Breather to the device manufacturers for recertifying their legacy devices but it is not allowing to delay all together entire process related to MDR compliance. Still there are many processes which needs to be made EU MDR compliant by manufacturer. 

Things to Remember for EU MDR Compliance

• • If we consider the timeline for certifications, which is approximately 2 years for high-risk devices and with the shortage of EU MDR compliant notified bodies, manufacturer do not actually have a time to procrastinate the preparedness to be EU MDR compliant. Possibly, this process again may turn to be costlier even from now. 
  • EUDAMED compliance dates are also prior to these proposed extension dates of EU MDR and which demands compliance to UDI, PMS, PSUR etc. This again goes back to compilation of technical documentation which need to be MDR compliant. 
  • Additionally, it is still not clear if registrations of device in non-EU countries are going to align their requirements with these EU MDR transition extensions. 
  • The most important aspect is this EU MDR transition extension to be considered is that, this is only going to be applicable to those manufacturers who had already made efforts to be MDR compliant and who had already implemented EU MDR compliant Quality Management System (EN ISO 13485). 

So, the message here is, instead of procrastinating this so-called obstacle of ‘EU MDR’, device manufactures can actually take this as an opportunity to create marketing advantage by building the competitive edge and to rush to be EU MDR compliant to gain the best possible advantage in this competitive market. 

We, at Operon with our Technical expertise, are here to help you to pass through all these obstacles and support you to be the leader in the market embracing the grace of becoming EU MDR compliant. Operon Strategist is a medical device regulatory consulting company who works in coordination with different regulatory bodies to provide regulatory services to clients.  We also help Medical device  manufacturers in obtaining CE Marking Certification for there devices.