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RQMIS

EU MDR / IVDR Transition

By now you've probably heard rumblings about the "EU MDR/IVDR". The EU, like any other geographical market, has its own set of regulatory requirements. These requirements were recently changed to the EU Medical Device and In-Vitro Diagnostic Regulations (EU MDR and IVDR) and are set to go into effect on May 26, 2021. This means that all medical device manufacturers have to comply with the new regulations by this date - and it's quickly approaching.

Now, it is true that about 85% of the MDR requirements are covered in the old MDD. However, even where the requirements are consistent, the MDR is actually more prescriptive in what evidence is required to demonstrate compliance. For example, are residual risks identified in your product risk profile represented in product labeling? This is a must under the new regulations.

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Here are some things you should do in order to comply with the new regulations:

  • Define and update your internal regulatory, clinical, and quality system processes to address the legal changes to the EU Medical Device and In-Vitro Diagnostic Regulations. We can perform a Gap Assessment which will identify areas of weakness in order to comply with the regulations.
  • Harmonize and integrate the updated processes with regulatory requirements from other markets in your distribution chain. Our regulatory experience with other global markets puts us in the perfect position for seamless integration.
  • Identify those products you want to continue distributing in the EU and update their respective Technical Files (TFs), including the Clinical Evaluation Reports (CERs). We have authored numerous TFs meeting the requirements of the EU MDR. A critical part of the TF is the CER, which we have successfully created per MEDEV Guidance 2.7/1 Rev 4.
  • Manage or support your ongoing Notified Body communication to meet business and regulatory timelines. Our team stands ready to handle all Notified Body negotiations and communications, including acting as your Authorized Representative if necessary.

The new MDR changes the market access landscape for all member countries of the European Union, and it aims to ensure a higher level of protection for patients and users. Some key changes associated with the MDR include:

  • Clinical Data: Companies will need to generate and provide more in-depth clinical data to prove safety and performance claims, including tighter equivalency standards
  • Global Products: Companies will need to rationalize their global product portfolios and perform a global impact assessment in order to implement the necessary changes to remain compliant

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EN/ISO Recertification Audits

RQMIS offers the following services to help you with the EU MDR / IVDR transition:

  • Training - We will train your staff to make sure your company has a thorough understanding of the new legislation and the changes from the current Medical Devices Directive (MDD)
  • Analysis - We will conduct thorough Gap Assessments to review your current products against the new legislation. The Gap Assessments consider the reclassification of certain product groups as well as MDR’s wider definition of a medical device
  • Product Line Assessment - We will assess your portfolio and determine the which products are considered "impacted products" versus "legacy products"
  • Action Plans and Surveillance - We will work with you to develop your company’s action plan for the EU MDR transition, and determine if new submissions to the Notified Bodies are required. We will then check the effectiveness of the plan once it is in motion, and monitor ongoing systems and processes
  • Ongoing Action - We will support your team with annual and long term updates required under the new MDR, including QMS and CER updates
  • Consultation - Our experienced team will always be available to support your MDR needs, especially during this transition phase

How will the EU MDR/IVDR change your current processes?

We can perform a gap assessment on your current operational processes to see where you need to improve in order to comply. Call us today at (978) 358 7307, or just click here:

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