Will 2021 be just as challenging as 2020 for medtech notified bodies?

N

otified bodies (NBs) are private organisations designated by EU states to assess the conformity of products before they’re placed on the market, whenever a third party is required. Many operate across numerous industries, but they’re particularly significant players in the EU’s medtech market, where they’re responsible for doling out the CE marks that allow medical devices to be sold in the region.

Along with almost every other sector in the world, medtech’s NBs found themselves forced to turn to remote working in 2020 as a result of the Covid-19 pandemic. Restrictions placed on travel and in-person social contact meant that eligible product audits were carried out remotely for much of the year.

These include surveillance and recertification audits, audits carried out when a manufacturer has filed a change notification or switched to a different notified body and audits on products considered essential due to Covid-19.

While auditing over Zoom sounds like it could be a relatively arduous process, a survey of medtech NBs by Team-NB found that the process has generally been successful. Of the 37 NBs surveyed, 97% said that their remote audits were generally successful, to varying extents.

Remote audits actually had a number of unique benefits over in-person ones, such as eliminating the need for travel and making it easier to involve experts across multiple geographies.

However, 57% of the NBs also reported that these remote audits took longer to conduct than on-site assessments. Poor network connections have been a common obstacle, as have the limited IT skills of some audited organisations and the hassle of scanning documents for processing.

A survey by Unity found some less obvious downsides to remote audits, including ‘missing soft facts’. Many respondents to Unity’s survey found that remote assessments meant that auditors were less able to pick up on the subtle signals that are more readily noticed during a face-to-face meeting or while touring a manufacturing facility. Half of Unity’s respondents felt that the quality of medtech audits would drop if they continued to be carried out virtually.

GlobalData director of therapy research and analysis Andrew Thompson says: “There is not so much an issue for auditors to actually now enter a site, many sites are ‘Covid Safe’. The issue is if they are coming from a third country, such as German auditors entering a UK, Irish or Chinese site.

“As long as governments put restrictions on visitors coming into countries, or impose restrictions on people returning from countries, some level of remote auditing is needed.”

For medtech NBs, and indeed the rest of the world, the light at the end of the tunnel has presented itself in the form of multiple successful Covid-19 vaccine candidates. As these are rolled out, the need for remote auditing should hopefully decrease in turn as the related restrictions are stripped away.

However, while this should hopefully leave medtech NBs in a much more familiar position this time next year, impending regulatory shifts mean that 2021 could prove to be quite a disruptive year.

In April 2020, the European Parliament voted to delay the implementation of the EU’s Medical Device Regulation (MDR) by a year to May 2021, to prioritise Covid-19 response efforts across the continent. MDR is intended to update the Medical Devices Directive (MDD) of 1992, broadening the definition of what counts as a medical device as well as having a more holistic focus on the entire lifecycle of a product rather than merely the approval process.

Many industry stakeholders were already pushing for a delay before Covid-19 hit, but months later little appears to have changed. The lack of on-site audits, coupled with a shortage of NBs that have brought themselves in compliance with the new rules, mean the MDR could still be unworkable for many devices by the time it comes into force.

Thus far, remote auditing has not been expanded to new certifications that will need to come in under the MDR. For these new approvals, 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 which need to be certified under MDR, but cannot be certified under MDD, could struggle to make it to market if an in-person audit is not possible.

MDR expands the definition of a medical device to include active implantable medical devices, which were previously categorised separately; software as a medical device; products for cleaning, disinfection or sterilisation of medical devices; and previously non-regulated non-medical or cosmetic devices like liposuction equipment or epilation lasers.

Another spectre hanging over the implementation of the MDR is the lack of NBs to have declared themselves MDR-compliant. If NBs don’t recertify for MDR, they can no longer issue CE marks for medical devices, but only 18 have gotten themselves ready to do so. Five have also said they’re pulling out of medical device regulation entirely, while the remaining 49 have yet to make an indication.

Thompson says: “Now there are fewer NBs, but probably the same number of annual certifications. Expect bottlenecks and delays in approvals.”

Another factor exacerbating these looming bottlenecks, particularly in the UK, is Brexit.

The UK officially left the EU in January 2020, however, it spent rest of the year operating under EU law during a transition period. Any regulation which came into place under EU law during 2020 stayed as part of UK law too. While it was previously understood that MDR would become part of UK law when it was due to kick in last May, this is no longer a requirement now that it will come into place after the transition period.

Thompson says: “The UK Government might simply adopt MDR as it is written. However, over the summer, it concluded a public enquiry into medical device safety, such as hernia mesh. The government has said it intends to take the findings of this enquiry to enhance the safety of medical devices.

“Safety is a major element of MDR, but it has regulations drawn up before we knew about these recent, horrendous, safety issues. It’s possible the government might conclude that MDR isn’t stringent enough and it might adopt a higher standard.”

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has outlined plans to keep on recognising CE marks until the end of June 2023, after which companies will need a UK Conformity Assessed (UKCA) mark to sell medical devices in England, Scotland and Wales. The situation is slightly different in Northern Ireland, which will remain under EU medical device law.

The MHRA is giving medical device companies four to 12 months to register for UKCA marks, depending on the risk class of the product. Companies based outside of the UK will need a responsible person in England, Scotland or Wales to bring their product to market.

These new regulations could all impact the number of medical devices eligible for approval and the routes they need to take over the next few years, and thus the operations of NBs. Many devices could be caught up in numerous approval processes at once, which could lead to a decline in volume of devices being approved. They should all still make it to market, but it’ll take more time.

UKCA marks will be designated by UK Conformity Assessment Bodies (CABs). UK NBs automatically became UK CABs in January – and they’re likely to have their work cut out for them.

“At some point between 2021 and 2023, a new British Medical Device Regulation will be introduced,” says Thompson. “I doubt there will be a hard stop in the old regulation, and there will be transition of old regulations. So, potentially, UK NBs still in business will be auditing devices to multiple different standards. At the same time, they may need to do more audits because there are less NBs than before.”