What is IVDR?
In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 is the new European legislation applicable to in vitro diagnostic (IVD) medical devices in the Europe. IVDR replaces the EU In Vitro Diagnostics Directive (IVDD) 98/79/EC. Manufacturers wishing to apply to a notified body for a conformity assessment of their IVD medical device have until the Date of Application of the IVDR on 26 May 2022 to update their Technical Documentation to meet the requirements and comply with the new Regulation.
The new Regulation brings significant changes to the regulatory requirements for IVD medical device manufacturers and introduces a new rule-based classification system with increased Notified Body involvement. The new rule-based system supersedes the current list-based approach in the Directive. This change means that, as classification rules will be applied to all IVD medical devices, up to 90% of IVD medical devices will require a Notified Body for conformity assessment.
In addition to the change in classification rules, there is also increased harmony between the IVDR and the Medical Device Regulation (MDR), the equivalent for medical devices, including a focus on clinical evaluation transparency through the wider supply chain.
Here are the major changes in addition to classification rules:
Performance evaluation
Post-market and vigilance
Quality management systems
Performance evaluation
A manufacturer is required to make a scientific validity report, analytical, clinical performance reports, and a performance evaluation report. The clinical evidence in these reports should support the intended purpose of a device as stated by the manufacturer.
Post-market and vigilance
The manufacturer is required to have a post-market surveillance plan and proactively collect and evaluate performance and relevant scientific data from the use of a device. The post-market performance follow-up (PMPF) should confirm the safety, performance, and scientific validity of the product during its time on the market and, particularly, the continued acceptability of the benefit-risk ratio and any new emerging risks or changes in the way the device is clinically used. Manufacturers will have to upgrade their current processes to meet the new requirements and ensure they have appropriate plans and reports in place.
Quality management systems
ISO 13485:2016 is the standard for the QMS. Manufacturers also need to include the IVDR in their routine internal audits before their first IVDR audit to ensure that the requirements have been addressed.
Our service offerings
- Regulatory strategy to transition to IVDR
- Gap analysis of the IVDR GSPR compliance
- Compilation of the technical file / STED
- Scientific Validity Reports
- Clinical Performance Reports
- Performance Evaluation Reports
- Writing/revising other documents such as package insert/IFU
- Quick Reference Instructions (QRI) and operation/user manual
- Post Market Performance Follow up (PMPF) protocols and Reports
- Post Market Surveillance (PMSR) Protocols and Reports
- Vigilance Reporting as per Article 82 of the IVDR
Key Differentiators
- Extensive In-vitro-diagnostics experience
- Assured IVDR compliance
- Expertise in EU IVDR key impact areas
- Strong project management to ensure schedule adherence
- Deep expertise in medical writing best practices
- Focused teams with cross expertise on specific impact areas and device categories
- Expertise to construct complex STEDs
- Quick to adapt to client culture and align for best results
