EU MDR Countdown
>> Update March 31: Please note that the EU MDR survey results are now available for download via this link. <<
As of today, there are less than 90 days left to ensure that your products comply with the requirements of the new Medical Device Regulation 2017/745 (EU MDR). According to Article 123.2, 26th May, 2020 will mark the end of the transition period, when the EU MDR comes into full force. Many changes will be applicable from this date, affecting manufacturers, importers, distributors and end-users worldwide.
For those still struggling to navigate EU MDR compliance within their own organizations, our EU MDR Survey might offer some new insights. See for yourself in which areas you are doing well and where there is still some catching up to do!
Major EU MDR Challenges
As the date of application approaches, medical device manufacturers still face several major challenges. One the one hand, there are lingering concerns about the availability and capacity of EU MDR-certified Notified Bodies. On the other hand, organizations face a lack of guidance from authorities as well as the EUDAMED delay. A shift in emphasis on the lifecycle approach will also bring challenges in data collection for proactive and reactive Post-Market Surveillance (PMS).
Organizations are expected to grapple with enhanced requirements for proactive PMS, including carrying out Post-Market Clinical Follow-up (PMCF) studies and making Periodic Safety Update Reports (PSUR), especially for higher-class devices. Reactive PMS involves gathering clinical data from several sources with shorter timelines to act on adverse events. Unannounced audits are expected to become more frequent under MDR, and implementing trackable data collection is inescapable.
While global players and those with >250 employees might have the financial and human resources to cope with the upcoming challenges, small- and medium-size enterprises (SMEs) are likely to be harder hit. With the EU MDR affecting so many critical processes from design, manufacturing to PMS and risk management, it is imperative for small manufacturers to implement a proactive strategy to ensure compliance before the deadline. Our EU MDR Survey contains 14 questions that assess how ready you are for the transition.
EU MDR Readiness Survey
Since implementing the EU MDR requirements comes with its own set of pitfalls, we at Climedo have created an EU MDR Survey to find out how far along you are on your transition journey. In this survey, we want to find out about:
> Your barriers to compliance
> Your Post-Market Surveillance strategy
> The status of your Notified Body
> Your vigilance processes
Climedo’s EU MDR Readiness Survey will enable you to validate your organization’s EU MDR compliance outlook. Assess the status of your implementation and compare it with your peers. Save time and streamline your effort by dedicating just 5 minutes to complete our EU MDR Readiness Survey!
Results of the EU MDR Readiness Survey will be published soon and also shared with you personally if you leave your email address.
If you have any questions, please reach out to firstname.lastname@example.org
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