Some important takeaways and considerations for approaching the MDR conformity assessment process from those who have been in the middle of it.
Nobody may yet actually qualify as a true veteran of the EU MDR. But those that have experienced at least some part of the MDR assessment process, either from the manufacturer or notified body perspective, are the closest thing we have. We recently spoke to MED-EL’s regulatory chief Elizabeth Gfoeller about her company’s experience as one of the first firms to earn CE marks under the MDR. (See “The First Wave: One Company’s Maiden Journey Through the MDR ,“ Market Pathways, July 17, 2020.)
Here are some key points to consider for a company approaching the MDR, from Gfoeller, as well as from Bassil Akra, CEO of consulting firm QUNIQUE and former TÜV SÜD executive, and Rita Guzzetta, VP of regulatory affairs for Medtronic plc’s CRHF (Cardiac Rhythm and Heart Failure). Akra and Guzzetta recently joined Gfoeller on a virtual panel on MDR conformity assessments convened by Xavier Health.