A variety of governmental entities in the EU are feeling pressure to address the issues with the rollout of the Medical Device Regulation, and some EU member states have taken matters into their own hands.

“The incomplete in vitro diagnostic regulation (IVDR) poses critical ongoing risks that need urgent resolution,” said Medtech Europe, as it welcomed the coming into force of the new EU regulatory system on May 26. Five years since the publication of the regulation, and after the industry has invested “significant resources into complying with its requirement,” some key elements of the infrastructure “are still not fully operational or even in place,” according to the trade body. “It is critical that all needed infrastructure is put in place and made operational without delay,” said Serge Bernasconi, CEO of Medtech Europe.

The mutual recognition agreement between Switzerland and the EU for medical devices lapsed in 2021, a development that was expected to add a significant amount of drag on Swiss device exports to EU nations.

As the implementation date of In Vitro Diagnostic Regulation (IVDR) looms on May 26, 2022, significant uncertainty remains around the new regulatory system. Under Directive 98/79/EC around 10% of all IVDs placed on the market need notified body involvement, whereas under the IVDR this will rise to 80%-90%. Notified body shortages continue to be a major challenge for industry, with many manufacturers yet to receive certification. The situation is expected to be particularly problematic for SME manufacturers who will see most of their products blocked on the market if they don’t receive validation in time.

The European Union’s (EU) Medical Device Coordination Group (MDCG) posted a guidance addressing verification of manufactured, high-risk in vitro diagnostics (IVDs), which indicates that manufacturers should submit samples to a reference lab for batch testing. However, the requirement for batch testing may not apply if no European reference lab has been designated for a test type, suggesting that some high-risk tests may go to market without adequate testing.

Makers of vitro diagnostics (IVDs) are facing several significant challenges in the next few years, thanks to existing and impending revisions to a number of regulatory frameworks. There are other considerations that are adding to the headwinds, such as a poor patent protection environment in the U.S., the net effect of which is to make life unusually miserable for developers of these tests.

The shortage of European notified bodies (NBs) for in vitro diagnostics has prompted calls from industry to delay the compliance dates for the In Vitro Diagnostic Regulation (IVDR), and the European Commission has responded with a proposed fix. The Commission proposed to give IVDs that are already on the market until May 2025 or later to obtain new CE marks, but the change requires the assent of the European Parliament and the European Council before it goes into force.

The EU’s Medical Device Regulation is now in full implementation mode, but the In Vitro Diagnostic Regulation (IVDR) won’t kick in until May 2022. Oliver Bisazza, director general of Medtech Europe, said that only six notified bodies are currently certified to review IVDs under the new regulatory framework, a predicament which suggests that many these tests will never again be available to patients.

The European Commission (EC) posted a new explanatory note on Tuesday that provides guidance on the codes set under the European In Vitro Diagnostic Regulation (IVDR) to define the notified body (NB) scope of designation and qualification required for assessing a device. The clarifications explain how to use the different levels of codes to guide the proper allocation of resources, citing the anticipated challenges with limited experience and competency of NBs.