Notified body group raises safety concerns about targeted MDR, IVDR revision

The European Association of Medical devices Notified Bodies (Team-NB) is concerned that some of the targeted revisions planned for the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) to ease postmarket surveillance requirements may compromise patient safety.

As such, the group is urging regulators to restore some of the surveillance requirements, as well as to address certain regulatory ambiguities within the regulations.

Earlier this month, Team-NB submitted comments to the European Commission on its concerns regarding revisions proposed by the Commission to address aspects of the MDR/IVDR intended to prevent medical product shortages in the regulatory region. While supporting the Commission's objectives, the group said that the changes could lead to significant problems for public health down the road.

"Team NB believes that the draft introduces a cumulative and systematic reduction of preventive regulatory safeguards, which increases risks to patient safety and public health," said Team-NB. "The proposed measures jointly reduce notified body involvement across certification and surveillance activities, including sampling, unannounced audits, surveillance audits, SS(C)Ps and PSURs, removal of recertification and expiry dates, and reduced transparency obligations.

"Viewed cumulatively, these changes would lower regulatory oversight to a level below that applied under the Directives (AIMDD/MDD/IVDD), shifting the EU system from a preventive to a predominantly reactive model," the group added.

Team-NB Director Francoise Schlemmer told Focus that after the revisions were proposed, they set up four working groups to assess the impact of the revisions and determined that the assessment activities were significantly reduced, which means less surveillance, less sampling, less in-depth reviews, less review of clinical information at various stages, and less unannounced audits. She emphasized the need to continue preventive actions under MDR/IVDR, as otherwise, regulators and manufacturers will be left to take corrective actions after issues are found with products, which can be more costly.

“Corrective actions are very costly… especially when you see that the overall activities today are less than 0.3% of the total EU medical device market,” said Schlemmer. “Even if you imagine that you are cutting by half the activities, what are you going to gain in terms of costs, what are you saving in terms of costs, and what are the risks that you are taking in terms of safety? That is our main concern.”

She acknowledged that the EU medical device and in vitro diagnostic directives were too lax, leading to medical scandals, and prompted the creation of MDR and IVDR. However, the proposed revisions could send the system back to the way it was.

“The bar was raised probably too high, but it's not a reason for now going backward, and even to a lower level than the directives,” said Schlemmer. “We need to find the right balance between what has to be done and what will give the right balance between safety and cost.

“As I have said, the activities of surveillance, cost is less than 0.3%, but the activities a manufacturer would have to do to reach that level are probably more,” she added. “More resources in terms of work to be done and collection of data… which takes time, money, and resources.”

Schlemmer said there is a need to reinstall some of the surveillance systems that were removed in the proposed revisions. She proposed creating a system in which manufacturers who have passed several audits, demonstrating a robust, sustainable regulatory system, would be rewarded with fewer, shorter audits. Ultimately, she said it would incentivize manufacturers to develop good regulatory systems.

Schlemmer also noted that the notified bodies ramped up hiring and training staff under the original MDR and IVDR a few years ago because there was a bottleneck in product applications seeking certification and recertification in the EU. She noted that since MDR went into effect in 2017, notified bodies have been adding 10% more staff year after year, leading to a doubling of auditors. However, she said now they may have too many resources, especially as manufacturers are holding off on submitting applications because they expect the revisions to take effect and reduce their regulatory requirements.

“It is really an issue for notified bodies,” said Schlemmer. “Some of them, which are the smaller ones, could even go bankrupt.”

She said that the notified bodies are in a conundrum because they don't know whether the revisions will go into effect as proposed, which could mean significantly fewer auditors are needed, or whether there will be further changes, which would mean they will continue to need many of those auditors to oversee products.

“We need to find the right balance of what has to be done in terms of surveillance to achieve a good level of safety without putting too much burden on the [medical device and IVD] sectors, because that is not the aim,” said Schlemmer. “The targeted revision, as it is, is putting additional administrative burdens, but less surveillance [burdens], on notified bodies.

For example, she noted that the Annex 7 changes impose timeline and clock-stopping requirements on notified bodies that are hard to invoice for.

Besides emphasizing that preventive actions are less costly in the context of public health, Schlemmer also said the revisions should be implemented to avoid further application bottlenecks. More specifically, she recommended that the four product classes be phased in under different deadlines using a risk-based approach rather than requiring all products to meet the new regulatory requirements in the revisions at the same time.

"We need to avoid bottlenecks," said Schlemmer. "If people do not want to think in advance, make them think in advance."

Schlemmer also said it's important to put in as much work as possible to develop clear definitions in the new revisions and resolve ambiguities, because otherwise it will lead to more regulatory disputes that are a waste of time.

Team-NB comment