The Regulation on In Vitro Diagnostic Medical Devices IVDR (EU) 2017/746, published on May 5, 2017 and entered into force on May 26, 2017, provides rules and requirements for placing on the market, making available and putting into service in vitro diagnostic Medical Devices from May 26, 2022.
IVDR replaces the current Directive 98/79/EC.
This regulation sets out many new and innovative requirements: the prescribed actions shall be organized in time in order not to be found unprepared at the time of full application of the IVDR (EU) 2017/746.
IVDR (EU) 2017/746: what do in Vitro Diagnostic Medical Devices Manufacturers have to do?
Below, the 6 most challenging aspects in the implementation of the Regulation that must be considered for a correct implementation of the same:
- Applicability Expansion.
On the in Vitro Diagnostic Medical Devices Regulation IVDR (EU) 2017/746, the scope of the IVDs is extended to include diagnostic services, genetic tests and other tests providing information on the predisposition of patients to develop a disease or on sensitivity to a medical therapy.
- Reclassification of devices according to the risk and intervention of Notified Bodies.
The in Vitro Diagnostic Medical Devices Regulation IVDR (EU) 2017/746 includes new reclassification rules for the IVDs according to their degree of risk (Class A for low-risk devices, Class D for high-risk devices). About the 90% of the IVDs, for which “self-certification” is currently envisaged, shall be reclassified according to the IVDR and they will require the certification of a Notified Body, in a more stringent and rigorous control context.
- More Documentation.
The in Vitro Diagnostic Medical Devices Regulation IVDR (EU) 2017/746 requires more formalization of content and more detailed information for technical documentation and to demonstrate the conformity of a device.
- Responsible Person.
Manufacturers shall appoint at least one Responsible Person for Regulatory Compliance, having a well-defined role, tasks and minimum requirements.
- Unique Device Identification (UDI).
Unique code allows to improve devices traceability and to make faster and more efficient a possible recall on products for which safety risks have been identified.
- Performance Evaluation (Vdp).
In order to continuously document the assessment of performance, Manufacturer shall create and update a Vdp plan specifying the characteristics and performance of the device, as well as processes and criteria applied to generate the necessary clinical evidence. The Performance Evaluation Report contains supported and sufficient data to demonstrate scientific validity, analytical performance and clinical performance of the device. Moreover, it is necessary to implement the Post-Market Performance Follow-up (PMPF), a continuous process of Performance Evaluation to be able to continuously update them throughout the entire product life cycle.
Do you want to get ready for May 26, 2022?
Trust our Thema consultants!
Thanks to effective field experience, our team of experts can support you throughout the IVDR (EU) 2017/746 preparation phase to initiate, from the outset, the necessary actions so that you will be ready before May 26, 2022, IVDR application date.
Do not wait any longer, there is so much to do. Below, you can see 5 key steps to implement a timely and effective regulatory strategy approach to this regulation:
- Carring out an accurate Gap-Analysis.
- Verifing the new classification rules.
- Checking your Technical Documentation and Quality Management System.
- Reviewing your product labelling.
- Preparing your Post-market Plan.
See our FAQ section! You will find the answers to some frequently asked questions about the IVDR (EU) 2017/746.
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