Similar to the previous two editions of DG, Article 18 should be relatively easy to understand. Each of the 27-Member States retains the right to enforce the IVDD and laws specific to their State. This includes the legal and regulatory oversight of IVDDs. Just a quick reminder for those of you that believe in the fallacy that the three Medical Device Directives, including the IVDD, are not really EU law; sorry folks, they are the law. Compliance with all aspects of the Medical Device Directives, including the IVDD, is mandated by EU law.

That being said, if a Member State believes that a medical device is in violation of EU law (IVDD) or is causing harm to their citizens, they have the legal right to:

• Refuse or block the entry of a device from entering the EU market;
• Restrict the placement of a device entering the EU market; or
• Force a RECALL, sorry EU market-withdraw.

As Dr. D stated in the opening paragraph, the Competent Authorities are required to notify the manufacturer and/or the manufacturer’s authorized representative prior to taking formal action. However, if one of the Member States believes a sense of urgency exists, and the public needs to be protected from a bad device, they can “Act first and ask questions later.”

It is one of Dr. D’s strong beliefs that device manufacturers should never reach the stage where Competent Authorities are informing them that a problem exists with one of their manufactured devices. If the vigilance and post-market surveillance programs, implemented by device manufacturers, are firing on all cylinders, there should never be any surprises. However, Mr. Murphy is alive and well; and mistakes are bound to happen, so device manufacturers must always be prepared to respond.

One final thought, remember the notified bodies? These are the folks that lease (rent) the use of their CE Mark to device manufacturers. Well (deep subject – the doctor knows) the Competent Authorities have a funny way of contacting the notified bodies when one of their lease holders (a.k.a., device manufacturers) has a device safety, efficacy, or regulatory issue forcing product  refusal, restriction or withdraw. Additionally, through the use of EUDAMED, all 27-Member States quickly become aware of the problem device(s). Ouch! No, really, a big OUCH! Eventually, the entire planet knows that a device problem exists, including FDA. Ouch, ouch, and ouch again!

By the time the Competent Authority, from one of the 27-Member States, is involved; all bets are off in regards to quickly mitigating a device safety, efficacy or regulatory issue, regardless of the problem being real or perceived. Remember Dr. D’s comment of “Act first and ask questions later?” Seriously, the doctor was not kidding. The Competent Authorities will act and act quickly.

The key to successfully placating the Competent Authorities is to execute an effective crisis-management plan. A response of “my bad” is just not going to work. As many quality and regulatory professionals are well-aware, an effective crisis-management plan is predicated on three salient fundamentals; (a) communication; (b) communication; and (c) communication. Oops, Dr. D forgot execution of the plan is important too.

All kidding aside, the offending device manufacturer should be prepared to be pummeled with questions from the Competent Authorities and the device manufacturer’s notified body. Depending on the device classification, the device manufacturer should be prepared to share the technical file or design dossier with the Competent Authorities, when requested. Trust the doctor when I say, “They will ask for the files; been there and done that (yeah – great grammar – but this is my blog).” That is why it is so darned important to keep these living regulatory documents current. Once a device manufacturer’s Chief Jailable Officer (CJO) has thrown him or herself onto the proverbial sword; and all of the appropriate corrective actions have been addressed; and the Competent Authorities are thoroughly convinced that the device safety, efficacy, or regulatory problems have been addressed; then just maybe, the devices will be permitted to re-enter the EU.

Before the doctor forgets, make sure the welcome mat is rolled out for the notified body. They just might be paying the offending device manufacturer a visit, at the device manufacturer’s expense. Did Dr. D mention device manufacturers pay dearly for the CE Mark rental? Just ask the person signing the checks made out to the notified bodies.

Medical Devices (IVDDs) should always be safe and effective in their intended use, while meeting all of the regulatory requirements delineated within the IVDD. However, when device safety, efficacy, or regulatory issues arise, the Competent Authorities will take action pursuant to Article 18 of the IVDD. That being said, there are two takeaways from this edition of DG: Takeaway one – any Member State, remember there are 27, retains the legal authority to refuse, restrict or force the withdraw of bad medical devices from their boundaries. Takeaway two – under Article 18 of the IVDD, notification of the device manufacturer and/or their EU authorized representative is required. However, if there is an overwhelming concern pertaining to the health and safety of the Member State’s population, Competent Authorities can act first and notify (ask questions) later. A “my bad” response from the CJO is just not going to work.

Until the next installment of DG, when Dr. D provides insight and guidance into complying with Article 19 (Confidentiality) of the In Vitro Diagnostic Medical Device Directive, a.k.a., IVDD – cheers from Dr. D and best wishes for continued professional success.