Overview

Due to the COVID-19 pandemic, European Union made changes in their upcoming Regulatory plans. The European Union’s new In Vitro Diagnostic Regulations (EU IVDR) was scheduled to come in action from May 2022 as a part of the new EU IVDR (2017/746). However, it is likely to be in effect a year later (May 2023) due to the COVID-19 pandemic.

EU Guideline (2017/746) overview :

Under the new guidelines, the EU IVDR will require approval from the notified body. This landscape of getting an approval from a notified body have increased a burden on manufactures and places a great demand for notified body in the EU. New notified bodies have been designated under the EU IVDR (2017/746) which now includes, BSI (Netherlands), BSI (UK) and DEKRA Certification. Although, the concern is the critical shortage is still growing.

The new EU IVDR (2017/746) has brought a lot of changes in the EU IVDR regulations. For example, the new EU IVDR risk-based classification will now introduce classification of the medical devices as per new required classification from Class A through Class D, Classes C and D being the highest risk.

CE Marking

To achieve CE marking, most manufacturers of Class B, C and D devices will be required to provide the information listed below to their notified body for review. Class A device manufacturers must register with a notified body and document the information listed below; however, it will not be reviewed by their notified body prior to EU market entry.

Technical documentation, as listed in Annex II, includes:
device description and specification

  • reference to previous and similar generations of the device
  • design and manufacturing information
  • general safety and performance requirements
  • benefit-risk analysis and risk management
  • product verification and validation

Clinical performance can be demonstrated through:

  • clinical performance studies
  • scientific peer-reviewed published literature
  • published experience acquired through routine testing

Changes made to EU IVDR ( 2017/746):

Changes to the EU IVDR (2017/746) include;


Design, production and quality:

  • Device design and manufacturing information should be included at all design stages, critical ingredients, instrumentation, software and manufacturing information on production, assembly, final product testing and finished device packaging.

Conformity:

  • The EU IVDR requires the EU Declaration of Conformity and other relevant copies of certificates to the competent authorities for at least 10 years after the device has been placed in the market.


Benefit-risk analysis and risk management:

  • According to article 10, EU IVDR brings out new levels of risk management expectations from the manufactures (Annex, Chapter I). Manufacturers have to follow the new EN ISO 14971 for compliance for risk-based analysis and risk management.


Performance Evaluation Report (PER):

  • As per the EU IVDR, manufacturers are expected to submit PERs for every year until the device stays in the market as a backbone from the submission.
    Periodic safety update reports (PSUR): These are extensions for PMS for class C and Class D devices. The PSUR should be updated at least annually for every group of devices, which should include, conclusion of risk0-benefit determination, summary of post-market clinical follow-up and sales volume if the device.

Labeling changes:

  • All labels must indicate that they are an IVD and contain a unique device identifier (UDI) as referenced in Article 24 and Part C of Annex VI. For sterile IVDs, or those which include sterile components, sterile packaging must be indicated as sterile, sterilization method noted, and instructions included pointing the end user to the instructions for use (IFU) should the sterile packaging be damaged or accidentally opened.

Regulatory Summary:

The regulations in EU has changed along with the transition from Medical Device Directive to Medical device Regulations and along with that, the manufacturers will feel strain of the continuous maintenance that is required for EU IVDR. Moreover, with the increasing demands and decreasing number of notified body during the transition, manufacturers need to prepare early. Additionally, due to the high demand, notified bodies are raising the price of their services. As a result, it is highly likely that a number of devices will be taken off the market, leading to shortages that may put at risk the lives of many EU nationals.

About Global Regulatory Partners:

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.

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