A Medical Device Coordination Group meeting regarding notified bodies and the forthcoming EU Medical Device Regulation and In Vitro Diagnostic Regulation, originally scheduled to take place in Brussels this week, is happening via teleconference, with certain sessions postponed, a European Commission spokesperson confirmed Wednesday.
The group of experts, which includes business and government interests, was slated to discuss designating authority for notified bodies, transitional provisions, joint assessments progress, setting up expert panels, next steps on Eudamed, and more, according to a draft agenda. The pivot to conducting the event virtually comes as the coronavirus spread across Europe has raised further doubts about the chance for smooth implementation of MDR, slated to take effect May 26.
Trade association MedTech Europe late Tuesday called for "a more European approach to contain the spread of the virus," criticizing decisions by authorities in member states including Germany and France to implement export bans on personal protective equipment. The group also encouraged the EC to take "a harmonised approach" in regulating companies responding to the outbreak to speed availability of diagnostic tests.
The EU already faced an uphill struggle to implement MDR in May without causing disruption to the availability of medical devices in Europe. Now, coronavirus looks set to make the struggle tougher still.
The potential disruption to the availability of already scarce notified body capacity comes as meetings in Brussels are canceled to curb the virus. Italy, which is home to one of the 11 notified bodies currently designated under MDR, is on a nationwide lockdown. To make matters worse, Germany, which houses more than one-third of the MDR notified bodies, faces a rising coronavirus burden.
On Tuesday, Italy expanded a lockdown covering a quarter of its population to the whole country. The Prime Minister told everyone to stay home, banned gatherings and limited travel to trips that cannot be postponed and must be made for valid work or family reasons. Italy took the actions after its coronavirus cases rose from 1,100 to 9,200 in nine days.
The lockdown will likely make it difficult for the Italian notified body designated under MDR, IMQ, to function as normal. IMQ is headquartered in Milan, the capital of the Lombardy region that is a focal point of the outbreak in Italy.
Losing access to IMQ would be a blow to the MDR implementation. However, the potential for the actions taken in Italy to be replicated in other parts of the EU in the coming weeks suggests there is scope for the situation to become considerably worse.
On Wednesday, German Chancellor Angela Merkel issued a stark warning, that 60% to 70% of the country's population could be infected. As of the latest World Health Organization situation report issued March 10, the country had 1139 confirmed cases.
If the virus spreads as quickly as it did in Italy, Germany could have more than 9,000 cases by the second half of next week. The potential for the number of cases to double every week or so from there on, and the resulting risk of overloading the healthcare system, could lead Germany to follow Italy’s lead and lock down some or all of the country.
The experiences of China and South Korea suggest such actions may enable European countries to arrest the exponential growth of the virus. However, given Italy and Germany account for 45% of the MDR notified bodies, it could also cause disruption to the device sector. The Netherlands, home to another 27% of MDR notified bodies, already has more cases per capita than Germany, creating the risk that another chunk of capacity will be knocked out.
Against that backdrop, the MDCG is discussing the state of play with MDR and IVDR in meetings not open to the public. The group convened Wednesday morning via web conferencing, which it will repeat Thursday morning. Afternoon sessions were postponed to a later date in March, an EC spokesperson said Wednesday.
Other EU events in Brussels have already been scrapped, with EU Monitor listing a meeting on artificial intelligence planned for Wednesday as canceled.
MedTech Europe on Tuesday issued a new statement on the novel coronavirus, calling on EU and national health authorities to ensure access to diagnostic tests, personal protective equipment and respiratory support equipment.
In particular, member states will need greater quantities of CE-marked COVID-19 tests. The trade association said to date, 28 IVD tests have received CE marks, most of which were developed outside of Europe and are reportedly not widely available in the EU. MedTech Europe said that manufacturers with sufficient volumes of tests and matching instruments installed throughout the EU "are now working towards compliance with the EU regulatory framework."