Be ready for the deadline of 26 May 2022 with ISO 13485:2016- and IVDR-compliant products.
We take the right measures with you to classify your products.
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.
A summary of the new IVDR Regulation.
- 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
- Change in risk classification
- Limited resources of the Notified Bodies
- Increased effort
- More rigorous clinical evaluation and documentation
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.
- 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
IVDR - In Vitro Diagnostic Device Regulation
Why not book a QuickCheck?
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.
- 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.