EU Approves New In-Vitro Diagnostic Device Regulation; Transition period has begun.

On April 5, 2017, the European Parliament approved the new In-Vitro Diagnostic Device Regulation.  This is the first major change in the IVD regulations. There is a five-year transition period following the formal publication of the IVDR for the industry to become compliant with the new regulation.  After 2022, any IVD sold in the EU must be certified under the new IVDR and companies must be in compliance with IVDR.

There are some major changes to these regulations concerning marketing IVDs in the EU.

Some highlights of the changes in the new regulation include:

• A new risk-rule classification system based on the Global Harmonization Task Force (GHTF) rules for classification. There will be four classes ranging from A (lowest risk) to D (highest risk).
  • Class A devices will be the responsibility of the manufacturer while all other classes will require notified body involvement.
• Most IVD’s will require a conformity assessment by a Notified Body.
• All devices will have to be CE marked under the new regulation.
• The scope of regulated IVD devices has been expanded.
• There are new labeling requirements for devices which includes a Unique Device Identification (UDI) number.
• An electronic portal will be introduced for post-market surveillance and vigilance monitoring.
• Performance evaluation reports including clinical evidence and post-market follow-ups will be required.
• Manufacturers have to be able to provide sufficient financial coverage for their potential liability depending on the risk of the device and the size of the company.
• IVD manufacturers must appoint a qualified person who is responsible for regulatory compliance to oversee implementation of the new IVDR.

Even though the deadline for IVDR implementation is 5 years away in the spring of 2022, it is important to begin planning your company’s transition to the new IVDR as soon as possible to ensure compliance.  As soon as the first notified bodies have obtained IVDR designation from the competent authorities, certification will become available.  With the shortage of notified bodies who will have the IVDR designation, it is expected that there will be severe delays in scheduling, so it is important to begin preparing as soon as possible.

We at mdi Consultants Inc. can assist with preparing your company to be in-compliance with IVDR before it is implemented.

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