Why is the new EU IVD Regulation creating a storm?

Just last week, we have discussed on the publication of the new European Medical Device Regulations (MDR), 2017/745. You can read about it here. The Regulations has come into force on 25th May 2017, marking the start of the transition period for companies selling medical devices into Europe.  Similarly, the in-vitro diagnostic devices (IVD) has gone from a Directive to an enforced Regulation – 2017/746.

The Product Owners of IVDs are facing one of the greatest challenges here, where all IVDs will be categorised into respective risk classifications, compared to the past, where almost 80% of IVDs sold in Europe are controlled by the self-declaration mechanism.


Nevertheless, this risk classification should not be unfamiliar to most, because it is adopted from the GHTF (Global Harmonisation Task Force). It is a four-tier system, which the IVDs are categorised accordingly based on their risk profile. Countries like Canada, Singapore and recently Australia, are operating in the similar model. Let’s take a quick look at this new IVDR risk classification:

EU IVDR Classification Table

Let's take a closer look at some of the changes in the IVDR:


#1: Conformity Assessment

From the ‘conformity assessment’ pathways, only Class A (non-sterile) IVDs may undergo the self-certification pathway. Sterile Class A, Class B, C and D IVDs now require an assessment by the Notified Body. Referring back to the Classification Rule Table, it’s important to identify your IVD’s classification and then work on the assessment pathway.

If you are working on a Class A (non-sterile) IVD, good news! You can start to move into the new regulations.


#2: Home-brew Kits

This was often one of the most controversial pathways for most Product Owners to explore in the past, but with this new regulation, the Dos and Don’ts are now more obvious. Tests kits can only be qualified as ‘home-brew’ when they meet the following criteria:

  • Are used within a single entity (e.g., a particular hospital)
  • No other tests available in the market that target this needs of a specific patient cohort
  • Meets ISO 15189 (Medical Laboratories – Requirements for Quality and Competence) requirements
  • Meets the General Safety and Performance Requirements of the new IVD regulation (Annex I)

A home-brew kit that falls into the definition of a Class D will have to meet additional requirements, on top of those mentioned above.


#3: Increased commitment to demonstrate safety and performance of your IVD

Companies have to continuously show that their devices are safe for use and can perform as required. This includes documents such as performance evaluation plan, post-market surveillance plan/report, post-market clinical follow-up reports, periodic safety update reports, and summary of safety and clinical performance.

For Class C and D IVDs, the performance evaluation report and the periodic safety update reports must be updated annually. Now, more resources have to be allocated so that all these activities can be diligently carried out!


#4 More transparency now with the EUDAMED system

For Class C and D IVDs, a summary of the general safety and performance information must be provided to the Notified Body for evaluation. Thereafter, it will be uploaded and made easily available on the EUDAMED for the users, patients and general public. Such information access was not required based on the previous Directives, which further emphasises the responsibilities of the Product Owners to ensure that the high risk IVDs are consistently safe and performs as required.

The Solution to your uncertainty

These are the only a few implementations that we have picked from the extensive list stated in the new IVD Regulation, which is a lengthy 157 pages, including all the articles and annexes.

However, fret not! We are having a workshop on 10-11 July, where we have invited the MT Promedt Consulting from Germany and TUV Rheinland auditors to discuss in details about the new EU regulations and possible implementation strategies that your company can adopt! Early-bird tickets are running out fast, so sign up here before 16 June to enjoy 20% off the original price! We look forward to seeing you then!