New European IVDR: What are the key areas of change to focus on?

What about leaving the EU?

Whilst some believe this is a great idea, it’s not an ideal solution, particularly if your main market is the EU27. For this, you need to maintain the CE mark.  The best solution is to get cracking with an ordered transition for both your business and its products.

Key areas of change

Even the difference in the volume of text between the IVD directive and the IVD regulation, for example, gives an indication there is a lot more to think about.  Consequently from these changes, this has increased from 60 pages to 175.

But what about businesses looking at this for the first time?  What are the key areas of change?

There are five key areas:

• Reclassification
• General Safety and Performance Requirements
• Clinical Evidence
• Post-Market
• Economic Operators

Reclassification

In the current directive, an IVD will either be classified in ascending risk as either General IVD, Self-testing, Annex II List B or Annex II List A.  Moving forward, the new IVDR uses 7 classification rules (see Annex VIII).  This is to be replaced with Class A, B, C & D; the latter being of the highest risk. An estimated 80% of IVDs on the market have gone under the radar as General IVDs.  This has allowed the manufacturers to self-declare conformance to the CE mark.  The new rules will re-classify a huge number of devices into higher risk classes, B & C.  For the first time, this means the conformity assessment will be performed by a Notified Body.

General Safety and Performance Requirements

Split into 3 chapters there are now 20 requirements, up from 13 in the IVDD.  Chapter 1 is more focused on risk management; must demonstrate benefits outweigh the risks; must reduce risk as far as possible.  Chapter II is calling for more detailed information concerning the analytical and clinical performance of the device.  Chapter III contains 108 sub-paragraphs regarding the device label and instructions for use.

Clinical Evidence

New to the IVD industry in the EU, the manufacturer must sufficiently demonstrate their device can achieve the intended clinical benefit and safety, when used as intended.  This evidence is now required in accordance with a Performance Evaluation Plan and collated as a report.  This will need to be continuous during the lifetime of the device.

Post-Market

With the requirement for Post-Market Performance Follow-up, the scope for Post-Market Surveillance has been broadened.  As a result, class C and D IVDs must have an annual update, as part of a Periodic Safety Update Report (PSUR).  Class A and B IVDs only need an update to reflect a change.

Economic Operators

In comparison to the existing directive, the responsibilities of each economic operator throughout the supply chain have been expanded upon.  The industry has been beset by scandal in the past and this is intended to provide a greater level of transparency and traceability.  Because of this, new requirements of note are UDI labelling and PRRC (Person Responsible for Regulatory Compliance).

Summary

To sum up, yes there is a hell of a lot of work for any business to do, and it is no mean feat to achieve.  However, with an organised, systematic approach to transition, meeting the new requirements can be accomplished.  But be cautious, the limiting factors to a successful outcome will be time and resources.  With notified bodies fast becoming a rare species, many will be at capacity and there will be far less designated to IVDR.  Internally your business probably hasn’t considered the full implications of the IVDR concerning time, resources and costs, so consider outsourcing.

IMed is experienced with performing a gap analysis to the IVDR and is on hand to help answer any questions and provide solutions.  If you would like to get in touch, please call us on 01295 724286 or email us at hello@imedconsultancy.com.