BRUSSELS — The European Commission this month launched the first component of its behind-schedule IT system for registering certified medical devices under looming new rules, but a regulatory bottleneck could render many products impossible to certify for some time.
The first of six modules of its Eudamed system will assign a "single registration number" to each medical device manufacturer, producer of procedure kits, importer, as well as the European representatives that non-EU manufacturers must have to get certified.
The database is incomplete and its roll-out two years behind schedule; it is now planned for completion when the In-Vitro Diagnostics Regulation takes effect on May 26, 2022.
The EU's Medical Device Regulation will come into force on May 26, 2021, delayed amid the pandemic after months of industry complaints that they wouldn't be ready before the coronavirus hit.
But COVID-19 restrictions, which prevent many on-site audits, along with the current shortage of notified bodies designated to operate under the incoming rules, mean many devices could be impossible to certify in time for the go-live date for MDR anyway, according to industry officials across several EU countries.
Groups including MedTech Europe have pressured the Commission to expand remote audits, occurring amid the pandemic, to new certifications under the incoming regulations on medical devices and in vitro diagnostics.
However, for new certifications, EU guidelines say remote audits are not allowed unless a case-by-case assessment finds them “relevant to ensure medical care, especially if clinically necessary during the period of COVID-19 restrictions."
Products that have to be certified under the new rules, but not the current ones, could be frozen out until on-site audits can resume, as they will not have the current CE marks to carry through into the new regime. That includes most devices covered by the IVDR, and MedTech Europe has said IVDR audits will need to take place in coming months for devices to be certified in May 2022.
Existing CE marks for medical devices can be renewed on the basis of audits done remotely by notified bodies via video link. Those certificates will remain valid until mid-2024 at the latest. But any recertification processed after the regulations come into force will be treated as an entirely new certification, which recent guidelines say must be audited on-site.
That means notified bodies are under pressure to recertify existing products under the current directives before the MDR arrives next May, said Caroline Dore-Geraghty, director of medical devices at the National Standards Authority of Ireland. The NSAI is also processing applications for new certifications under the MDR.
"Very few notified bodies at this moment in time are taking new products on under the old directive, because a medical device doesn't just get certified overnight," Dore-Geraghty said. "It can take between six months for a lower-risk device, to maybe two years for a high-risk device."
"I really have problems in seeing how we will be able to meet the market needs with products if we are not allowing these virtual audits," added Anna Lefevre Skjöldebrand, chief executive of Swedish Medtech, a national industry association.
The Swedish approach to COVID-19 restrictions has been less aggressive than other European governments. Nevertheless, Skjöldebrand said companies follow official advice. "When it comes to the audits, I wouldn't think it'd be such a big difference between Sweden and other European countries," she said. "On-site audit is really an obstacle that is hard to deal with."
Skjöldebrand argued that remote audits should be generally allowed for new certifications, on the condition that an on-site audit is done as soon as possible.
A spokesman for the European Commission said it is currently discussing "the possible need for the use of remote audits under the new regulations and to which extent this could be deemed formally possible."
Even before the MDR's postponement, the slow progress of Eudamed and the shortage of notified bodies meant rumors of a delay were already circulating in Brussels by February.
Despite the extra year for implementation, as of early December only 17 notified bodies have been designated under the MDR, compared to 54 under the 1993 EU medical device directive, one of two directives the MDR will replace.
For the IVDR there are just five designated notified bodies, whereas the current in-vitro diagnostics medical devices directive has 21. Nevertheless, the Commission spokesman said that "the bigger notified bodies are all designated under the new regulations."
Any company anywhere in the world can apply to any notified body in any EU country, as long as it's authorized to certify that type of product.
"The lack of notified bodies is really stressful for the members [of Swedish Medtech]," said Skjöldebrand. She said the shortage makes it very difficult for firms to obtain CE marks under the new rules. "The pace of designating notified bodies has been much slower than what was assumed."
Dore-Geraghty said part of the reason for the slowness was a lack of official guidance about the legal requirements for agencies applying to become notified bodies.
"The regulation was supposed to be so easily read that guidance documents wouldn’t be necessary — but guidance documents are necessary, because of varying interpretations among notified bodies, among competent authorities, among manufacturers," noted Dore-Geraghty. She added that the Commission also still has not appointed the expert panels required to review notified bodies' certifications of high-risk products.
While the MDR implementation deadline is sooner, the IVDR is a bigger challenge for manufacturers because over 80% of the devices that require certification do not have to be certified under the current rules, stressed Phil Brown, director of regulatory and compliance at the Association of British HealthTech Industries. Stephen Lee, ABHI's director for diagnostics regulation, said "notified bodies are not guaranteeing anything less than 12 months" to process a request for certification under the IVDR.
Now outside the EU, Britain will not adopt the MDR/IVDR, but to be sold in the EU, U.K.-made medical devices will need EU certificates (just as European products will need British certificates to be sold in the U.K.). The British Standards Institute (BSI) is a designated notified body for both regulations, having established offices in the Netherlands.
"We certainly question whether the remaining IVDR transition time is tenable," said Oliver Bisazza, MedTech Europe’s director of regulations and industrial policy. He said the EU "should consider" delaying implementation of the IVDR.
While Bisazza doesn't think the MDR needs to be delayed again, he said it is "essential" that the EU finds solutions to the audit problem, such as by allowing virtual audits, so that manufacturers with compliant devices are not left unable to get certified.