By now most of you are probably growing tired of hearing about all of the changes lurking on the horizon when it comes to the MDD. Everything from unannounced notified body audits to a rescript of the directive into a regulation injected with steroids. Now granted, it would be nice if the entire world could come together and script a global medical device regulation. However, this type of medical device utopia is not likely to happen in Dr. D’s lifetime, but the doctor can dream can’t he.
For this week’s guidance, Dr. D will dive into some of the changes device manufacturers can expect with the recast of the MDD into a regulation. Trust the doctor when I write; “This recast will probably not be the “magnum opus” (look-it-up) of medical device regulations.” It follows the typical five-year pattern of switching things up in the EU. Besides, where is the fun in having the medical device industry remain in a static state when it comes to device regulations? However, make no mistake it is the goal of the regulatory authorities in the EU to drive safety, efficacy, and innovation in the world of medical devices. That being said, the doctor hopes you enjoy this week’s brief guidance.
What to expect
Just in case, you are not already aware or happen to reside in a cave, notified bodies have always retained the right to show up on your door-steps unannounced for the purpose of performing an audit. Out of courtesy to their clients they seldom exercise the right to do so. Besides, if the establishment consists of just a handful of individuals, a surprise visit may net a locked door or the not having the appropriate people available to entertain an audit. Guess who picks-up the tab if no one is home when the notified body shows up “unannounced” for a cup of coffee and an audit?
Other areas expected to improve, or at least be viewed differently, with the recast of the MDD into a regulation include:
- Scope clarification to ensure all medical devices are correctly classified and assessed for safety and efficacy;
- Better supervision and oversight of notified bodies;
- Clarification of rules, rights, and responsibilities for authorized representative, manufactures, importers, and distributors;
- Expansion of European Databank (EUDAMED)utilization to include patient, healthcare professionals and general public access to data specific to medical device availability;
- Enhanced device traceability through the application of a Unique Device Identification to support better post-market safety and efficacy in medical devices (better control of product recalls – Dr. D’s favorite six-letter word);
- Stronger rationale and requirements for clinical evidence in support of submissions;
- Promotion of the concept of state-of-the-art in medical devices;
- The re-class of some devices;
- Creation of a Medical Device Coordination Group (MDCG) comprised of members of Competent Authorities;
- A review of Class III Device applications (design dossiers) by the MDCG;
- A requirement for device manufacturers and the EU reps to retain “qualified persons” with at least 5-years of regulatory experience;
- Adaption of rules to promote applicable safety and performance requirements for new technologies, including software;
- Improved coordination between national authorities to ensure that only medical devices that are safe and effective are placed and retaining in the EU marketplace; and
- Probably the most challenging, enhanced alignment to international standards in pursuit of facilitating international trade (e.g., singing a few bars of kumbya).
The doctor will leave the readers with just one takeaway this week; cha-cha-cha-changes are coming in the EU. In fact, the doctor strongly suggests that you remain in close communication with your notified bodies as they are in a position to provide your organizations with the latest information. If prying information from your notified body is similar to pulling teeth, then just maybe, your organization may have the wrong notified body. Remember, you pay your notified bodies. They work for you. Similar to any divorce, divorces from notified bodies can be painful; however, they may also be necessary for an organization to be successful and ultimately, grow. Finally, if your notified body isn’t providing the information you seek; visit the EC Europa Website.
In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment of DG – cheers from Dr. D. and best wishes for continued professional success.