EU IVDR
Placing your in-vitro medical device in the EU market
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
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.
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.
Post-market and Vigilance
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.
- 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
Our Service Offerings
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
CLIENT TESTIMONIALS
We work continuously to receive customer feedback to provide them unmatched value. Here is what they say about us.
“Toby has had a smooth journey with Saraca Solutions. They have provided us with both a highly experienced Quality Manager and a very energetic Quality Engineer. Specifically, I would like to thank Saraca for closing our NCs in a timely manner while simultaneously performing a gap analysis on our entire QMS. Additionally, in preparation for an upcoming ISO audit, Saraca performed an internal audit on all of our major Quality subsystems. Lastly, Saraca Solutions faced our 2017 ISO audit, hand in hand with our staff, at Toby headquarters. I appreciate the end to end support provided by Saraca Solutions. This magnitude of interaction is unique among engineering services companies in the area of medical devices."
"Saraca was extremely helpful to our Product Team’s understanding of the requirements of ISO 13485 by presenting it to them in a simple and effective manner. They have also done a commendable job in helping us to align our deliverables in-line with the ISO 13485 requirements. With their help, our team was able to understand & implement the ISO 13485:2016 requirements effectively within a short duration. Their planning and execution methodology is superb. Overall, we are very happy with the outcome of our association with Saraca Solutions."
“Our team has partnered well with SARACA Solutions as we continue the development process for submitting one of ENT products for 510(k) review with US FDA. They constructed and maintain a Design History. They are also working on Risk Analysis as defined by our Quality Management System. The SARACA team has shown the depth of their experience working in the industry while seamlessly integrating well with us. In addition, their methods of collaboration ensure effectively developing the documentation and processes for our product management.”
Case Studies
We have provided a few projects which we have executed for our customers. Please reach out to us for more details.
