Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

IVDD Article 18 – Decisions in Respect of Refusal or Restriction

By Dr. Christopher Joseph Devine
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Dr. Christopher Joseph Devine, President, Devine Guidance International

Article 18 does provide for an open channel, ensuring lines of communication exist between the 27-Member States, their Competent Authorities, the offending device manufacturer, and the device manufacturer’s European Authorized Representative.

Article 18 (Decisions in Respect of Refusal or Restriction) of the IVDD (98/79/EC) delineates the notification requirements for Member States pertaining to the refusal, restriction, or decision to withdraw of bad medical devices from the European Union (EU) device market. In short, Member States can execute their legal right, under Article 18, stating their case; a device manufacturer’s medical devices are hurting or have the ability to hurt their citizens. Can you say the Member States do not want these devices entering their borders?

The good news, for the device manufacturers of IVDDs, is that there is a notification process, with manufacturers having the opportunity to respond to any and all planned Competent Authority actions driven by Article 18.

The bad news is, each of the 27-Member States retains the right to act, without prior notification, when they believe a device presents a “clear and present danger” (sounds like a movie) to the health of their general public.

Regardless, Article 18 does provide for an open channel, ensuring lines of communication exist between the 27-Member States, their Competent Authorities, the offending device manufacturer, and the device manufacturer’s European Authorized Representative.

One final note before the doctor dives into this week’s tirade. As Dr. D burned up his laptop’s keypad, typing this week’s guidance, he stopped to marvel at the evolution of technology. Without a laptop, MS Word™, and spell check, the doctor’s weekly posting would be filled with multiple examples of cacography (look-it-up).

The IVDD – 98/79/EC
Article 18 – Decisions in Respect of Refusal or Restriction
1. Any decision taken pursuant to this Directive:
(a) to refuse or restrict the placing on the market or any making available or putting into service of a device, or
(b) to withdraw devices from the market, shall state the exact grounds on which it is based. Such decisions shall be notified without delay to the party concerned, who shall at the same time be informed of the remedies available to him under the national law in force in the Member State in question and of the time limits to which such remedies are subject.
 
2. In the event of a decision as referred to in paragraph 1, the manufacturer or his authorized representative shall have an opportunity to put forward his point of view in advance, unless such consultation is not possible because of the urgency of the measure to be taken as justified in particular by public health requirements.
What IVDD medical device manufacturers need to know
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!

What IVDD medical device manufacturers need to do
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.

Takeaways
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.

 
References: 

  1. Devine, C. (2009, July). Exploring the effectiveness of defensive-receiving inspection for medical device manufacturers: a mixed method study. Published doctoral dissertation. Northcentral University. Prescott Valley, AZ.
  2. Devine, C. (2011). Devine guidance for complying with the European medical device directive – MDD. Charleston, SC: Amazon. 
  3. Devine, C. (2011). Devine Guidance series on complying with the MDD. Published in The Medical Device Summit
  4. Directive 98/79/EC. (1998, October). Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices Retrieved September 12, 2011, from http://eur-lex.europa.eu.

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Dr. Christopher Joseph Devine, President, Devine Guidance International

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