BRUSSELS — The European Commission this month launched the first component of its lagging IT system (Eudamed), which is used to register certified medical devices before new regulations take effect. However, regulatory bottlenecks could leave many products uncertified for some time.

The Eudamed system consists of six modules in total, and the first module launched this time will assign a "single registration number" to each medical device manufacturer, surgical kit producer, importer, and authorized representative designated in the EU by non-EU manufacturers.

The database is still incomplete and its launch has been delayed by two years from the original schedule; it is currently planned to be fully built by the time the In Vitro Diagnostic Medical Devices Regulation (IVDR) takes effect on May 26, 2022.

The EU Medical Devices Regulation (MDR) will take effect on May 26, 2021, a date postponed due to the pandemic. In the months prior, the industry had complained about being unable to prepare before the COVID-19 outbreak.

However, according to industry officials in several EU countries, COVID-19 restrictions (these measuresprevented many on-site audits) and the current shortage of notified bodies designated to operate under the new rules mean that many devices may not be certified in time for the MDR effective date regardless.

Industry groups, including MedTech Europe, havepressured the European Commissionto expand the scope ofremote auditsconducted during the pandemic to new certifications under the new rules.

However, for new certifications, EU guidelinesstipulatethat remote audits are not allowed unless a case-by-case assessment deems them "necessary to ensure medical care, especially when clinically needed during COVID restrictions."

Products that must be certified under the new rules rather than current regulations could be excluded until on-site audits resume, because they have no existing CE mark to carry over to the new system. This includes most devices covered by the IVDR. MedTech Europe says IVDR audits need to be conducted in the coming months for devices to be certified by May 2022.

CE marks for existing medical devices can be renewed based on remote audits conducted by notified bodies via video link. These certificates are valid at the latest until mid-2024. But any recertification processed after the new rules take effect will be considered entirely new certification, and the latest guidelines require on-site audits for such certification.

Caroline Dore-Geraghty, director of medical devices at the National Standards Authority of Ireland (NSAI), said this means notified bodies are under pressure to recertify existing products under current directives before the MDR takes effect next May. NSAI is also processing new certification applications under the MDR.

"Currently very few notified bodies are accepting new products under the old directives, because medical devices cannot be certified overnight," Dore-Geraghty said. "Low-risk devices may take six months, while high-risk devices can take up to two years."

Anna Lefevre Skjöldebrand, CEO of Swedish Medtech, added: "If virtual audits are not allowed, I really struggle to see how we can meet market demand for products."

Sweden's response to COVID restrictions has been less stringent than that of other European governments. Nevertheless, Skjöldebrand said companies still follow official recommendations. "In terms of audits, I think Sweden will not differ much from other European countries. On-site audits are indeed a difficult hurdle to overcome," she said.

Skjöldebrand believes that remote audits for new certifications should be generally allowed, provided that on-site audits are conducted as soon as possible.

A European Commission spokesperson said discussions are ongoing about "the possible need for remote audits under the new rules, and to what extent this can be considered formally feasible."

Even before the MDR was postponed, the slow progress of Eudamed and the shortage of notified bodies had already led to rumors of a delay circulating in Brussels in February.

Despite the one-year extension, as of early December only 17 notified bodies had been designated under the MDR, compared with 54 designated under the 1993 EU Medical Devices Directives (one of the two directives the MDR will replace).

Only 5 notified bodies have been designated under the IVDR, compared with 21 under the current In Vitro Diagnostic Medical Devices Directive. Nevertheless, the Commission spokesperson said "the larger notified bodies have all been designated under the new rules."

Any company worldwide can apply to any notified body in any EU country, as long as that body is authorized to certify that type of product.

"The shortage of notified bodies is putting enormous pressure on Swedish MedTech members," Skjöldebrand said. She said the shortage makes it difficult for companies to obtain CE marks under the new rules. "The designation of notified bodies is far slower than expected."

Dore-Geraghty said part of the slow progress is due to a lack of official guidance on the legal requirements that organizations applying to become notified bodies should meet.

"The regulation was supposed to be easy to interpret, so no guidance documents were needed — but guidance documents are necessary because there are differences in interpretation among notified bodies, competent authorities, and manufacturers," Dore-Geraghty noted. She added that the Commission has still not appointed the expert panels needed to review notified bodies' certification of high-risk products.

Phil Brown, director of regulatory and compliance at the UK's Association of British HealthTech Industries (ABHI), emphasized that while the MDR implementation deadline is closer, the IVDR is a bigger challenge for manufacturers because over 80% of devices requiring certification are not certified under current rules. Stephen Lee, ABHI's director of diagnostics regulation, said "notified bodies do not guarantee processing times of less than 12 months for IVDR certification applications."

The UK has now left the EU and will not adopt the MDR/IVDR, but to sell in the EU, UK-made medical devices need EU certificates (just as European products need UK certificates to sell in the UK). The British Standards Institution (BSI) is a designated notified body for both regulations and has established an office in the Netherlands.

"We really question whether the remaining IVDR transition period is feasible," said Oliver Bisazza, director of regulatory and industrial policy at MedTech Europe. He said the EU "should consider" postponing the IVDR implementation.

While Bisazza believes the MDR does not need to be postponed again, he said the EU "must" find a solution to the audit issue, such as allowing virtual audits, so that manufacturers of compliant devices are not left uncertified.