MedTech Europe is calling for the European Union to act urgently to ensure medical devices and in-vitro diagnostics (IVDs) can stay on the market when new regulations come into force.
The trade group argues that the slow pace of progress over the past 14 months means there is a risk the required critical infrastructure will not be ready by the end of the transition periods.
The group is asking the EU to hit pause on the countdown to implementation or delay the deadlines to ensure there is enough time to put functioning systems in place.
In May 2017, the EU adopted regulations that radically change the requirements faced by producers of medical devices and IVDs. The incoming regulations require 35,000 IVDs to gain CE marks for the first time and necessitate the recertification of 314,000 devices that went through the process under the old rules. At the same time, the notified bodies that certify medical devices and IVDs must get designated by the EU under its new, more stringent requirements.
EU officials established three and five-year transition periods for the medical device and IVD rules, respectively, to give the sector the time to take these actions. However, MedTech Europe is worried that many essential elements are still missing with 22 months to go until the end of the medical device transition period, leaving its members with little time to certify or recertify their products.
The notified body designation process takes an estimated 18 months. As MedTech Europe is yet to see a “big bang” in designation applications, it fears a shortage of notified bodies will stop companies from getting their products certified by the end of the transition periods. That could force companies to pull products from the market. The problem is compounded by doubts about whether notified bodies can access the talent they need and the risk a hard Brexit will affect certification capacity.
MedTech Europe’s warning to the European Commission, the European Parliament and EU member states also identified other elements that at the current rate will not be ready in time. As it stands, the EU has published two of the 18 mandatory implementing acts that will detail the standards and specifications with which organizations must comply.
Given the danger that some essential elements of the regulations will not be ready in time, MedTech Europe wants the EU to reconsider its trajectory. The trade group proposes either stopping the clock on the countdown to the end of the transition periods, or delaying the implementation dates for all products or just legacy products. MedTech Europe also wants the EU to change the existing “grace period” so it allows more products to stay on the market after the end of the transition periods.
The warning marks an escalation of MedTech Europe’s long-standing concerns about the feasibility of the transition periods. However, it is questionable whether the EU will grant the trade group its wish. The EU would need to formally reopen the regulations to change the deadlines, raising the risk that the painstakingly-reached compromise positions in the text would be revisited and challenged.