Expertise.
IVDR Consulting.
Be ready for the 26 May 2022 deadline with ISO 13485:2016- and IVDR-compliant products with Consulting from Entourage.
Together.
Together we take measures for product classification.
Comprehensive.
We find gaps in QMS and technical documentation.
In line with the market.
Bring your products to the EU market.
Time until the new regulation.
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IVDR Consulting needed?
A brief summary of the new IVDR Regulation.
Complex.
- New classification system A to D
- Technical documentation even more detailed
- Increased involvement of Notified Bodies
- Preparation of the performance evaluation
- Stricter vigilance requirements
Critical.
- Change in risk classification
- Limited resources of Notified Bodies
- Increased effort
- More rigorous clinical evaluation and documentation
In a hurry.
The European Commission End of May 2017 a extensive, challenging
Regulation published. The IVDR resolves the IVDD (98/79/EC) already in May 2022 from.
Groundbreaking.
- 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 IVDR Consulting from Entourage.
- Essential requirements (Annex I)
- Technical documentation
- List A / List B and Other
- Quality assurance system
- Performance evaluation
- 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)
IVDR Consulting needed?
Book our QuickCheck now.
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 performed to see which products will be submitted under the IVDR and which ones were removed from the product portfolio.
Outcome.
- Prioritization and classification of products for the creation of 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 authority
Become a part of the team.
Entourage is looking for life science professionals.
How we can support you with IVDR Consulting.
- GAP analysis of the existing technical documentation
- Classification of products
- Preparation of QMS documents (PMS etc.)
- Preparation of the technical documentation
- Support in performance evaluation
- 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)
