Despite major changes coming to the EU regulatory system in under two years, many companies are still scrambling to develop strategies for handling the MDR and IVDR implementation in the region.
Last month at DeviceTalks West, Abbott regulatory affairs director Caroline Leab Byrd, R&Q regulatory affairs director Nancy Morrison and 30-year regulatory vet Artha Nafie ran through some basic steps that companies should take in preparation for the shift in the regulatory landscape.
“EU MDR will require companies act before full clarity is available on what is required. Guidance and level setting will occur over time, but you cannot wait and it is necessary to start with the requirements in the regulations and follow the intent of the requirements to guide actions,” Morrison told MassDevice.com, commenting on the workshop. “The level of clinical evidence required is growing even under the existing medical device directive, and will continue to intensify with the EU MDR.”
Despite the changes only being a year off, a large number of companies don’t have a significant understanding of the changes, and over half have no strategy for tackling them, according to Byrd, who referenced a survey from the Regulatory Affairs Professionals Society.
“Those statistics, how real are they? They’re real,” Byrd said. “It’s what you’ve seen in the industry, it’s what you’re feeling from your colleagues, and it’s what I’m hearing from colleagues outside. It’s such a complex thing.”
Though there are naysayers who claim that the changes won’t reach implementation, panelists agreed that there’s very little to no chance that the shift won’t go into effect, and waiting to implement an appropriate strategy will only hurt a company in the long run.
“I always like to start my plan with where I’m going to be at the end, at the end of the day. I’m going to have products that are compliant. I’m going to stay on the market. And I’m not going to kill my people in the process of getting there,” said Morrison of R&Q, which sponsored the workshop at DeviceTalks.
Morrison suggested that regulatory specialists turn their views internal and focus on their own organizations to identify the best area to start to implement changes for the MDR and IVDR rules.
“I sometimes appreciate a new regulation because it gives me permission to throw out the bad stuff,” Morrison said.
She added that that the new rules would give companies a chance to examine systems that aren’t functioning up to their desired quality and improve them, and therefore improve quality overall.
“The whole point is protecting patients,” Morrison said.
Despite the focus on protecting patients, panelists said that there will likely be a number of devices that come off the market as a result of the shift.
Because of this, they added that it is important that companies stay in close communication with their notified bodies to make sure that they are doing all they can to keep their life-saving devices on the market.
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Will these new rules affect current RoHS & REACH regulations in the US? Thank you.