Celegence Webinar: Taking advantage of the EU MDR Delay in Uncertain Times

• What: Webinar in conjunction with RAPS showing you how to take advantage of the EU MDR delay.
• When: July 22nd 2020, 11.00am – 12.30pm EST
• Where: Online Event
• How: Register online now
• Why: You will learn what the EU-MDR extension means for your organization, and how the extra time should be leveraged for both new and legacy devices.

On 24 April 2020, an amendment to the EU Medical Devices Law (MDR) (Amending Regulation) was released by the EU legislator postponing the implementation of the EU MDR requirements by one year, until 26 May 2021. The medical devices industry awaited the adoption of the proposal of the European Commission to postpone the implementation of essential sections of the new EU MDR by one year. This postponement would bring much-needed relief to the medical device industry and the EU Member States for whom the ongoing COVID-19 pandemic poses an immense burden.

As a reason for this delay, the European Commission said it wanted to ease the pressure from competent authorities, notified bodies, manufacturers and other authorities to focus on the current COVID-19 crisis rather than on the MDR’s last minute preparations.

Webinar Registration Is Open Now!

Is your organization facing hurdles regarding MDR certification? What about recertification under MDD? Join RAPS and Celegence for a webcast where regulatory leaders from global medical device companies will share their perspective and lessons learned regarding the challenges – both past and future – related to EU MDR.

Secure Your Place Now!

The following is the tenth in the series of EU MDR related blogs. In this blog, we will give you an overview of what you can expect from our upcoming webinar with RAPS on Taking Advantage of the EU MDR Delay in Uncertain Times.

To learn more about the EU MDR changes you can view some of the previous posts in the series:

• Medical Device Equivalence vs Demonstration of Equivalence
• Post-market Clinical Follow-up Requirements for EU MDR
• The New European Union MDR: Impact on Technical Files
• Low-risk Device Challenges
• Selecting and Working with your Notified Body
• Medical Devices with Ancillary Medicinal Substances
• Regulatory Challenges Writing EU MDR Compliant Clinical Evaluation Reports (CER)
• International Medical Device Regulators Forum (IMDRF) & Summary of Recent Changes to Clinical Evaluation Guidance
• Remote Medical Audits During COVID-19

Several regulatory authorities have provided guidelines for clinical trials (FDA, MHRA, EMA) on how to move to remote monitoring during COVID-19. Even if the MDR is delayed, it is now time to get prepared and plan to hit the ground running with the collection of clinical data.

COVID-19 affects device manufacturers and suppliers significantly. Device manufacturers are likely to see a drop in sales for appliances primarily used in elective and surgical procedures. They are reassessing marketing and revenue forecasts and have to consider how safety measures will impact production lines, as well as any effect on resource allocation and funding of remediation programs for MDR.

Shifting the MDR date of application gives Notified Bodies an opportunity to continue being designated under the new regulation and ready to accept applications from manufacturers. Medical device manufacturers should expect Notified Body availability and reviews to be further delayed by the COVID-19 situation.

The COVID-19 pandemic affects clinical trials, production, and supply chains, as well as Notified Body readiness and other regulatory concerns. However, the lesson is that the medical device industry must still be EU MDR compliant and should not lose its focus. So how will this additional year allow the medical industry to prepare for a completely planned and effective implementation of the MDR? Make sure you join our webinar to find out.

Webinar Registration Is Open Now!

Is your organization facing hurdles regarding MDR certification? What about recertification under MDD? Join RAPS and Celegence for a webcast where regulatory leaders from global medical device companies will share their perspective and lessons learned regarding the challenges – both past and future – related to EU MDR.

Secure Your Place Now!

During this webinar, hosted in conjunction with RAPS, Regulatory leaders from global medical device companies will share their perspective and lessons learned regarding the challenges – both past and future – related to EU MDR. In addition, you will develop a comprehensive and advanced understanding of potential strategic solutions for MDR compliance, regardless of where you are in the transition process. You will also learn how to take advantage of the extension for both MDD renewal and MDR implementation.

By attending this session, you will gain access to industry and Celegence experts who can answer your questions on the hurdles your organization is facing in MDR certification and recertification under MDD.

• Gain an understanding of what the EU-MDR extension means for your organization, and how the extra time should be leveraged for both new and legacy devices
• Strategize for upcoming audits based on common NB findings and pitfalls; understand the beneficial tactics you can use in a virtual audit
• How to use the time to work with NBs, Economic Operators, and implement all recently published MDCG Guidance
• Strategize for interactions with specific extra-EU situations: Switzerland and Turkey

• Quality managers
• Regulatory managers
• Technical writers
• Operations managers
• Design managers
• Technical managers
• Clinical managers
• Authorized representatives in representatives in Europe

The Taking Advantage of the EU MDR Delay in Uncertain Times webinar will be held on July 22nd 2020 from 11-12.30pm EST. Make sure you secure your seat at the webinar by registering now.

Webinar Registration Is Open Now!

Is your organization facing hurdles regarding MDR certification? What about recertification under MDD? Join RAPS and Celegence for a webcast where regulatory leaders from global medical device companies will share their perspective and lessons learned regarding the challenges – both past and future – related to EU MDR.

Secure Your Place Now!

As regulatory specialists, we work across all phases of the product lifecycle from regulatory strategy, authoring, and all aspects of established product maintenance, including submission management, publishing and health authority interaction. We leverage a global team of consultants to provide local regulatory insight, strategy and intelligence. We are happy to share our insights with you through the webinar with RAPS and hope that you can join us then, make sure you register now.