The EU Medical Device Regulation (MDR) was initially for entry in May 2020. But right before two months, EC or the European Commission proposed for the delay of the compliance deadline for one whole year. Parliament had unanimously voted on the 17th of April 2020, and the member states adopted this proposal one week later.
Although the delay comes as a relief for manufacturers of medical devices currently under hefty pressure, organizations must become complacent. Postponing efforts and taking prerequisite steps to promise the conformity of the devices by next year (May) is of no use.
What’s The Purpose of This Delay?
Offering businesses one whole extra year extra months to be ready is just one side effect of the EU MDR delay. European Commission already realized how COVID-19 had put an abundant strain on medical facilities, providers, and distributors experience optimized demand. This, in turn, forced them to redirect the resources.
There’s a dearth of recently certified devices. It contributes to pulling products from the market that cannot comply with the MDR requirements. It would pose a risk to the health of people.
What Do You Mean By EU MDR?
The MDR happens to be an almost complete overhaul of the predecessor MDD. It’s extensively widening the opportunities of application and distinctly geared toward transparency on the safety of patients throughout devices’ lifecycle.
What Should You Learn About EU MDR Delay?
The delay is just a short breath of something new. In around ten months, the European Medical Devices Regulation is set to come into effect. Just in case you slowed the pace in the compliance action plan, it would be the right time to choose it now.
EU offers you the right time to assess the studies pertaining to the various options, available resources, and progress achieved. Despite the economic uncertainties, it is important to practice the exercise of business introspection. The following are what you need to evaluate;
- The right time duration and place where the resources mostly get needed currently
- Whether or not you have sufficient in-house capabilities for the purpose of covering an array of MDR
- Whether you are willing to take the eyes off the global health crises and its recovery to enter the race
- Whether or not you are confident about the suppliers and that they have active and responsive engagement
- Whether you have the ideal technologies as well as operational bandwidth in order to tackle compliance priorities, globally and domestically
Pertaining to the most recent environment and the challenges to forecast the forthcoming months, resolve options might seem lesser. Assuming that there would be another delay, there are more complications. Putting the MDR as uncertainty can only lead to more stress and strain on budgets as well as manpower.
The Bottom Line
The EU MDR delay highlights its commitment to assist healthcare systems and businesses in controlling the crisis. It would not be a great decision to delay getting premium-quality performance tools that contribute to benefits from additional time.
Is MDR delayed?
MDR Delays in the application date of multidrug-resistant tuberculosis were implemented to allow hospitals and medical facilities to continue to supply devices during the crisis of the pandemic.
Why was EU MDR introduced?
The European Union Medical Device and Drug Regulation (MDR) aims to ensure a high level of safety and quality of medical devices manufactured or supplied in European Union member states.
What does EU MDR mean?
The deadline to ensure compliance with the European Union for Medical Devices Regulations (EU MDR) is approaching.
When did MDR come into effect?
The new European Union Medical Device Regulation (EU MDR) was published in the Official Journal of the European Union on May 5, 2017.