In June 2021 the Medical Device Coordination Group (MDCG) published on the website of the European Commission the IVDR Preparation and Implementation Plan (EU) 2017/746 for in vitro Diagnostic-Medical Devices (IVD) “Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic Medical Devices (IVDR)”.
The MDCG, with the input of the interested parties, has established the priorities and the system that will enable the monitoring of the progress in the implementation of the in vitro Diagnostic-Medical Devices Regulation.
A real challenge for the implementation of the IVD Devices Regulation
The document underlines that, despite the efforts made, the implementation of the IVD Regulation remains a real challenge, further aggravated by the actions that had to be taken to address the Covid-19 health emergency. Since the beginning of the pandemic, IVD Manufacturers have been absorbed in rapidly developing and increasing the production of Covid-19 tests, which has made them divert their resources from activities aimed towards IVDR compliance.
In addition, less than one year after the date of application of the Regulation, there are still few designations of Notified Bodies that can certify IVD devices.
But these are not the only critical issues. The IVD industry will also face the following problems:
- Long and complex certification process. For Class B, C and D IVDs requiring the intervention of a Notified Body, the certification process takes between 13 and 19 months.
- Few guidance documents useful for interested parties.
- Delays for full functionality of the EUDAMED database. To date only the 1st module “Actor registration module” is active on the platform. The 2nd module “UDI Registration and Devices” and the 3rd module “Notified and Certified Bodies” will be available by September 2021. The remaining modules will be released when EUDAMED is fully operational.
It is important, therefore, that the European Commission, the Member States and all involved parties are responsible for ensuring the full implementation of the IVDR by resolving these difficulties.
Why has the IVDR Preparation and Implementation Plan been published?
In view of the full applicability of the IVD Devices Regulation, the Plan aims to establish the priorities for the implementation of the Regulation and to monitor the concrete actions that need to be taken by Member States, by the European Commission and by all interested parties to ensure that the IVDR (EU) 2017/746 is operational from 26 May 2022.
The timeline of the activities to be carried out will be constantly updated to keep pace with the progress of the work.
What are the priorities?
The IVDR Preparation and Implementation Plan divides the priorities into two categories:
- Set A – essential actions – which includes the actions essential to ensure that IVD devices can effectively access the European market. For example:
- Emergency planning and monitoring.
- Availability of Notified Bodies.
- European Union Laboratories to consult for any necessity.
- Set B – high priority actions – which includes all those guidance documents which are expected to be published to facilitate the work of interested parties such as:
- Common Specifications.
- Guidelines for Notified Bodies.
- Standards.
How to prepare for the implementation of the IVDR Regulation (EU) 2017/746?
Here are 5 useful tips for you and your company:
- Perform a precise Gap Analysis.
- Check the new classification rules for IVD devices.
- Check the Technical Documentation.
- Involve relevant business functions to implement all requirements.
- Rely on a team of experienced IVD advisors to implement the strategies and actions needed to be ready by May 26, 2022.
Do you know that Thema can fully support you in the process of adapting to the IVDR (EU) 2017/746?
The processes to be undertaken in order to comply with the IVDR (EU) 2017/746 are long and demanding and action must be taken as soon as possible in order to be ready for full implementation. Through our strategic-regulatory consulting services, we can follow you step by step in the implementation plan of the regulation.
Contact us for more information!
Are you a Manufacturer of IVD Devices and want to know in detail what the obligations provided by the IVDR (EU) 2017/746 are? Download our White Paper “Factsheet for Manufacturers of in vitro Diagnostic Medical Devices”.
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