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EU MDR / IVDR Regulation

By now you've probably heard rumblings about the "EU MDR and EU IVDR". The EU, like any other geographical market, has its own set of regulatory requirements for medical device registration. 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 EU regulations by these dates - and it's quickly approaching.

Now, it is true that about 65% of the Invitro Diagnostic Medical Device Regulation (IVDR) requirements are covered in the Invitro Diagnostic Directive (IVDD). However, even where the requirements are consistent, the IVDR is actually more prescriptive in what evidence is required to demonstrate compliance. For example, are residual risks identified in your medical device risk profile represented in the medical device labeling? This is a must under the new EU regulations.

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EN/ISO13485 Certification for a Chinese Manufacturer

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 (MDR) and In-Vitro Diagnostic Regulations (IVDR) for your medical device.
    RQMIS can perform a Regulatory 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 for your medical device.
    RQMIS’ regulatory experience with other global markets puts us in the perfect position for seamless integration for helping your regulatory department.
  • Identify those medical devices 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 and EU IVDR. RQMIS also is medical device authorized representative (AR, EC Rep)
  • Manage or support your ongoing Notified Body / Health Authorities communication to meet business and regulatory timelines for your medical device.
    RQMIS’ team stands at the ready to handle all Notified Body and health authorities negotiations and communications, including acting as your European Authorized Representative if necessary.

The new Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR) 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: Medical Device / In-Vitro Diagnostic manufacturers will need to generate and provide more in-depth clinical data to prove safety and performance claims, including tighter equivalency standards
  • Global Products: Medical Device / In-Vitro Diagnostic manufacturers will need to rationalize their global medical device portfolios and perform a global impact assessment in order to implement the necessary changes to remain compliant

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

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EN/ISO Recertification Audits

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

We can perform a Medical Device / In-Vitro Diagnostic - EU regulation gap assessment on your current operational processes to see where you need to improve in order to comply. Are you ISO 13485 certified? Do you need help in your ISO 13485 certification? Is your medical device technical file documentation ready for the MDR / IVDR submission?

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