Regulations for IVDs have remained passive in comparison to those for drugs and medical devices for several years. In Vitro Diagnostic Regulation (IVDR 2017/746) under European regulations will make the system predictable and robust through transparency and maintain sustainability.

Where to Begin? Areas to focus on in your IVDR Gap Assessment

Recent data shows that under the IVDD only 10-20% of the IVDs are scrutinized by the Notified Bodies. With the introduction of the IVDR, it will rise to 80-90% thereby simultaneously increasing the number of Notified Bodies to review the IVDs.

IVDR Gap Assessment

It’s time to evaluate your clinical and performance data because it is utmost importance for Class B, C and D IVDs and also A if applicable. Under IVDR (Article 56), compilation of performance evaluation report, scientific validity, analytical performance, and clinical performance report for each device is necessary.

Vigilance will be the area of focus under IVDR and you need to display a continuous improvement in your risk management process. Implementing a post-market performance follow-up plan (Chapter VII & Annex III) is a major part of it.

Under IVDR continuous feedback and evidence is needed to portray that the risk management procedures undertaken are adequate. Simply displaying compliance with EN ISO 14971:2012 will not suffice.

Implementing UDI for IVDs will become mandatory under IVDR as the new system will focus more on supply chain traceability. If you are currently compliant with the US FDA norms then the process is known to you but the format and mechanism will differ.

EN ISO 13485:2016 certification is mandatory under IVDR except for Class A IVD Devices. So it’s time to get one if you still don’t have it. For those currently complying with US FDA QSR (21 CFR Part 820), have a higher chance of an easy transition to IVDR.

IVDR Compliance challenges

  • Transition strategy With less time in hand to shift from IVDD to IVDR, it is necessary to have a proven strategy. Begin by sorting out the confusion and choosing the relevant Notified Body. Bring all the evidences together.
  • Prioritization of product portfolio Scrutinize each of your devices and assess them depending on the part they play in the entire product portfolio of the company. Keep in mind the surging clinical and regulatory costs.
  • Lots of Documentation & Labeling updates Under the IVDR (Annex II & III) provides the list of content needed as part of technical documentation for each product. Supply chain complexities within IVDR designate each distributor as “economic operators” and they would be vested with regulatory and legal responsibilities.
  • Interpretation of Requirements The main aim behind all these changes is to establish a “quality management system.” If you are trying to operate within the EU then it is high time to ensure that you are complaint with EN ISO 13485:2016.

IVDR Transition approach

Phase 1


Thoroughly assess each of your products and collect existing data on QMS, Technical documents, Product data, Labelling, Performance, and Stability.

Phase 2

Pilot & Planning

Segregate products that are more profitable through product classification and the gap analysis already mentioned. Plan ahead to close the gaps.

Phase 3

Remediation & CE Marking

CE marking by a Notified body is essential to get qualified as an IVD under EU. Accumulate all the documents that might be necessary in the process.

Phase 4

Life Cycle Management

IVDR covers the entire product lifecycle with continuous evaluation. Technical Document needs regular assessment and new norms to be followed to monitor and report post-market performance.

We’re here to help

Want more information? Get in touch with us.