Further revisions to the MDR and IVDR

Last week, the European Parliament (EP) passed a resolution calling on the European Commission (EC) to further revise the Medica Devices Regulation (MDR)¹ and In Vitro Diagnostic Medical Devices Regulation (IVDR)².

As with most revolutions, the MDR/IVDR revolutions have been bumpy and have significantly disrupted the availability of medical devices and IVDs in Europe. Over the last 5 years, the EC has made multiple corrections and extensions to attempt to ameliorate the impact. The demand for changes has come from multiple stakeholders including: patient organisations, public health bodies, the pharmaceutical and MedTech sectors. 

The EP is now of the view that the corrections were insufficient and has called on the EU to take various steps, including to:

• adopt multiple implementing acts to address the most pressing challenges that the MDR and IVDR have generated by the end of Q1 2025;
• undertake a systematic revision of MDR/IVDR; and
• resolve divergent interpretations of MDR/IVDR that have arisen.

The EP calls for:

• the elimination of unnecessary re-certification of products, the EP being of the opinion that certain product updates or adjustments should not necessarily lead to an entire re-certification of the product; and
• the urgent full implementation of EUDAMED, which is a crucial but significantly delayed cornerstone of the MDR/IVDR framework.

Importantly, the EP also called on the EC to take steps to improve the performance, transparency and accountability of Notified Bodies. The most notable of these is to impose binding timelines on Notified Bodies. This is a much-needed measure to ensure the timely CE marking of medical devices and IVDs before they can be placed on the market or put into service. 

More excitingly, the EP has also called for the introduction of:

• special rules to expediate access to “orphan” and “paediatric” devices; 
• fast-track approval pathways for innovative technologies to address unmet medical needs and health emergencies.

All stakeholders have welcomed the resolution. 

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[1] Medical Devices Regulation (EU) 2017/745

[2] In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746