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Expertise.

IVDR readiness.

Be ready for the deadline of 26 May 2022 with ISO 13485:2016- and IVDR-compliant products.

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Together.

We take the right measures with you to classify your products.

Clean.

We identify gaps in the QMS according to ISO 13485:2016 and in technical documentation.

In line with the market.

Get your products ready for the European market.

Time until the new law.

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In force since May 2022.

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A summary of the new IVDR Regulation.

Complex.

  • New classification system A to D
  • Technical documentation even more detailed
  • Stronger involvement of the Notified Bodies
  • Preparation of the performance evaluation
  • Stricter vigilance requirements

Critical.

  • Change in risk classification
  • Limited resources of the Notified Bodies
  • Increased effort
  • More rigorous clinical evaluation and documentation  

Hurry.

The European Commission has End of May 2017 a extensive, challenging
regulation published. The IVDR replaces the IVDD (98/79/EC) already in May 2022 from.

Pioneering.

  • Classification of IVDs According to risk
  • Definition of common specifications
  • Marking by means of UDI
  • Electronic Market surveillance
  • Designation of the "person responsible for regulatory compliance" Article 15 Person
  • Electronic market surveillance (EUDAMED)

From IVDD to IVDR with Entourage.

IVDD - In Vitro Diagnostic Device Directive

  • Essential requirements (Annex I)
  • Technical documentation
  • List A / List B and Other
  • Quality assurance system
  • Performance evaluation

IVDR - In Vitro Diagnostic Device Regulation

  • General safety and performance requirements (Annex I)
  • Technical documentation (Annex II)
  • Technical documentation on post-market surveillance (Annex III)
  • Conformity assessment (Annex IX or X, or XI)
  • Declaration of conformity and marking (Annex IV, V)
  • Support for UDI and traceability Annex VI
  • Data message EUDAMED
  • Classification rules ( Annex VIII) 
  • Interventional clinical performance studies and others (Annex XIV)

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Case Study.

Preparation of the Technical Documentation for submission to the Notified Body under IVDR.

The client, a large global player, is preparing its products for the IVDR. First, a GAP analysis was carried out to see which products would be submitted under the IVDR and which were removed from the product portfolio.

Outcome.

  • Prioritisation and classification of the products for the creation of the technical documentation
  • Templates and templates were created and adjustments made in the SOPs (e.g. PMS).
  • Example product was gradually transferred to the IVDR TD
  • TD could be successfully submitted to the appointing body

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The Entourage is looking for life science professionals.

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How we can support you.

  • GAP analysis of the existing technical documentation
  • Classification of the products
  • Preparation of QMS documents (PMS etc.)
  • Preparation of the technical documentation
  • Support in performance assessment
  • Search for a suitable Notified Body
  • Submission of the technical documentation to the notified body
  • UDI preparations
  • Literature research
  • Communication with Notified Body
  • MDSAP (preparation / audits)
  • Audit (ISO 13485:2016)