Europe’s upcoming rules on registering medical devices like ventilators should be postponed until after the coronavirus pandemic, manufacturers say.
Device manufacturers worldwide are trying to ramp up production of essential products such as ventilators and get them cleared and shipped to health systems as quickly as possible. The new regulation, slated to take effect in May, could make it harder to get products needed to help with Covid-19 approved for sale amid a shortage of protective medical equipment and diagnostic tests.
The request to postpone the European rule is pending as President Donald Trump confused the issue last week by stating that countries in the European Union won’t accept device imports from the U.S. Attorneys say that’s not quite right, although the rules for each jurisdiction are slightly different.
In order for medical devices to be sold in Europe, they must get the certification mark, or “CE mark,” showing the product conforms to with health, safety, and environmental protection standards within the European Economic Area. That’s now regarded as easier than getting approval in the U.S.
But the European Union Medical Device Regulations (EUMDR) could change that, attorneys say. “In Europe it has been, until the EUMDR, relatively easy to get that CE mark, which allows you to sell your product,” Pat Shafer, a managing director in Grant Thornton LLP’s Healthcare and Life Sciences Industry practice, said.
“Even U.S. companies have pretty often sought to get that CE mark in Europe first. What’s happened is that Europe has generally recognized that the pathway to approval of a medical device in Europe has been too lax. Generally, the U.S. has required greater clinical evidence. That is changing with the EUMDR regulations.”
The new European regulations are intended to maintain patient safety while keeping up with scientific and technological advances.
“As far as changes under the EUMDR in terms of clinical performance, there’s a more robust requirement that many devices demonstrate a clinical safety and efficacy that was not in place before,” Marty Zuzulo, the compliance and risk director at Grant Thornton LLP, said.
The update brings a tighter focus on how devices show safety and effectiveness after they hit the market. The rule says companies should gather more information by running regular clinical evaluations.
In emergency situations such as Covid-19, however, it may be harder and not as safe for manufacturers to run these tests.
Waiting Out the Pandemic
Europe’s medtech industry won’t have ample time to learn how to comply with the incoming regulations and also respond to the pandemic crisis. MedTech Europe, a trade association, says the rules should be postponed for at least six months, or until the World Health Organization says the pandemic is over.
“Currently and for the next few months, helping healthcare systems to overcome this outbreak is and will be in everyone’s top priority and focus. Manufacturers are striving to keep needed medical technologies available to healthcare systems while managing the effects of the pandemic on their organisations,” MedTech Europe said in a March 23 letter to the European institutions.
Members of the European Parliament shared the same sentiment in a March 24 letter to the European Commission.
“Healthcare systems across Europe are diverting resources to meet the demands posed by the Covid-19 crisis, including the provision of sufficient safe medical devices such as ventilators,” the legislators said.
Not for Sale
Trump said March 25 that U.S. medical technology companies can’t sell their products in European Union countries, citing the EU’s “specifications.” The statement raised eyebrows within the industry and caused a flurry of questions.
The new European rule shouldn’t change how devices are imported or exported from the EU, according to Alexander Roussanov, a partner at Arnold & Porter in Brussels and a former senior legal adviser in the Legal Department of the European Medicines Agency.
“The MDR regulation replaces the existing directive,” Roussanov said, adding that he doesn’t expect the update to “prevent imports from the U.S.”
There are currently restrictions in various countries that prevent some products made with certain materials from coming into that specific country. But that shouldn’t slow imports and exports in emergency situations because federal governments are doing what they can to ensure they get what they need, Shafer said.
“At the end of the day, there are many restrictive regulatory issues, but with the virus, this is all about the balance between safety and efficacy and availability and what are the compromises we need to make in times of crisis. Of course, that will definitely change once the pandemic ends. But for now, this is about the tools that agencies are using to circumvent traditional regulations.”