IVDR Regulatory Framework Update

The In Vitro Medical Devices Regulation (EU) 2017/746 (IVDR), sets out the new regulatory framework for in vitro diagnostic (IVD) medical devices.

To prevent disruption to the supply of essential medical devices as a result of Covid-19 pandemic related delays, in October 2021, the European Commission proposed a progressive roll-out of the IVDR. The adoption by the European Parliament and European Council of the Commission's proposal will lessen anxieties around IVD certification bottlenecks and subsequent product shortages.

Amended transitional periods will depend on the type of device in question:

Class of IVD	Proposed end of transitional period
Higher risk devices such as class D devices (including HIV or hepatitis tests)	May 2025
Class C devices (such as influenza tests)	May 2026
Lower risk devices in class B and A (such as sterile devices)	May 2027
In-House devices	May 2024
IVDs with a certificate under the IVDD (issued by a Notified Body before 26 May 2022)	May 2025

Next Steps

We recommend that manufacturers immediately determine what classification of IVD their products fall into and consider how best to comply with the proposed new deadlines from May 2022.

Mi3 are the experts in contract medical device design, development and manufacture providing comprehensive medical device regulatory consulting services throughout our customers' journey. With our Quality Management Systems (QMS) certified and audited to ISO 13485:2016 via the Medical Device Single Audit Programme (MDSAP) Mi3 will ensure your products are fit and safe for the market they are intended for.

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