Expertise.
IVDR readiness.
Be ready for the deadline of 26 May 2022 with ISO 13485:2016- and IVDR-compliant products.
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.
Interested?
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)
Need?
Why not book a QuickCheck?
Case Study.
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
Become part of the team.
The Entourage is looking for life science professionals.
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)
