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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 Regulations and In-Vitro Diagnostic Regulations (EU MDR and EU IVDR) and are set to go into effect on May 26th, 2021 and May 26th, 2022 consecutively. This means that all medical device manufacturers have to comply with the new regulations by these dates - and it's quickly approaching.

Now, it is true that about 65% of the MDR requirements are covered in the Medical Device Directive (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 actions we highly recommend you take to comply with these 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.
    RQMIS 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.
    RQMIS’ 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 Documents, including the Clinical Evaluation Reports (CERs).
    RQMIS has authored numerous Technical Documents meeting the requirements of the EU MDR.
  • Manage or support your ongoing Notified Body communication to meet business and regulatory timelines.
    RQMIS’ team stands at the 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

RQMIS can help support you through the transition in the correct way.

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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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