In October 2021, the Medical Device Coordination Group (MDCG) published the “Joint implementation and preparedness Plan for Regulation on in vitro diagnostic Medical Devices (IVDR)”, an update of the Implementation Plan and preparedness for IVDR (EU) 2017/746 Regulation.
A decision made to avoid inconvenient
The decision originated by the necessity to ensure a trouble-free transition to the new IVDR (EU) 2017/746 Regulation -fully implemented from May 26, 2022- despite factors, such as considerable delays in adjustments and limited resources available following the Covid-19 pandemic, that, as we all know, have led the European Commission to propose an extension of certain deadlines, which has not been approved yet at the time being.
The implementation Plan and preparedness of IVDR (EU) 2017/746 Regulation prioritises the necessary activities according to their impact on public health, patient safety and regulatory transparency.
In particular, the plan lays down the essential and high priority actions to be undertaken before May 26, 2022, IVDR (EU) 2017/746 Regulation date of full application.
Essential actions for IVDR implementation and preparedness
In the Plan, among the essential actions, there are some activities to be completed within the next six months, which are divided into three topics:
- Contingency planning and monitoring which includes essential action such as:
- establishing a forum for EU Member States to communicate risks and critical issues related to IVDR implementation, and to ensure an appropriate availability of products;
- monitoring market and stakeholders and addressing any product shortages.
- Availability of Notified Bodies which concerns the shortage of Notified Bodies necessary to satisfy adjustment requests from the in Vitro medical diagnosis devices industry. In this scenario the actions established are:
- find experts in the EU Member States to oversee NB’s joint assessments;
- find effective systems so that NB can carry out conformity assessments during COVID-19 pandemic;
- find a way to increase NB capacity to satisfy the big number of CE marking requests under IVDR Regulation.
- EU reference laboratories contains essential actions to designate what promises to be a novelty in IVD sector, namely EU reference laboratories, entities mainly dedicated to performing additional pre-market tests on Class D devices.
High priority actions for IVDR implementation
High priority actions are described as non-essential for Manufacturers to place their IVD devices on the market, but still useful to facilitate the work of the parties involved.
These actions cover the following:
- Common specifications.
- Guidance for notified bodies.
- Performance evaluation.
- Standards which IVDR refers to.
- Companion diagnostics.
- In-house devices.
Do you have to comply with IVDR (EU) 2017/746 main obligations?
Thema can fully support you in the adjustment process to IVDR.
If you wish your company to be ready to market IVD devices starting from May 22, 2022, date of full application of the IVDR, you must act as soon as possible.
Contact us for a consultancy!
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