2019, EU regulatory reform


On January 2, 2019, despite major changes in the EU's regulatory system in two years, many companies are still working on strategies to deal with MDR and IVDR implementation in the region.

Last month Nancy Morrison, director of regulatory affairs at DeviceTalks West, Abbott Caroline Lieb,R&Q, and Artha Nafie, a 30-year regulator, went through some of the basic steps that companies should take to prepare for a change in the regulatory environment. "the EU MDR will require companies to act before they get the full clarity they need. Guidance and level setting will occur over time, but you can't wait, it's necessary to start with regulatory requirements and guide action as required, "Morrison told the, Review Seminar." "even under existing medical device directives, the level of clinical evidence required is growing and will continue to intensify as MDR in the EU continues to grow." Lieb says that while these changes are only a year old, many companies do not have a good understanding of them and more than half have no strategy to address them. He cited a survey by the Association of legal Professionals. "how real are the statistics? They're real, 'said Lieb. "this is what you see in the industry, that's how you feel about your colleagues, and that's what I hear from outside colleagues. This is a very complicated matter. "despite opposition claims that these changes will not be achieved, team members agree that there is little chance of such a shift and that waiting for the right strategy will only have a long-term impact on the company. "I always like to start my plan at the end of the day. I will have a product that meets the requirements. I intend to remain in the market. And I'm not going to kill my employees when I get there, "said R & Q's Morrison, who sponsored the seminar at DeviceTalks. Morrison recommends that regulators put their views inside and focus on their own organizations to identify the best areas to begin implementing changes to MDR and IVDR rules. "I sometimes appreciate a new rule because it allows me to abandon the bad things," Morrison said. She added that the new rules would give companies an opportunity to improve overall quality by examining and improving systems that do not meet expectations. "the focus is on patient protection," Morrison said. Despite their focus on patient protection, team members said that as a result of the shift, it was likely that some devices would be removed from the market. Therefore, they added, companies must maintain close communication with their certification bodies to ensure that they do everything they can to put their life-saving equipment on the market.