Article 8 (Safeguard Clause) of the IVDD (98/79/EC), establishes the requirement for the removal of medical devices suspected of hurting the patient or user, when such devices are employed in their intended use. Can you say “RECALL?” Yep, there goes Dr. D throwing around that nasty six-letter word.
But seriously folks, if an IVD medical device is racking up the vigilance reports, it needs to be pulled from the market. You can call it a correction, withdraw, recall, or make up your own name; just get the product off the market. That being said, the “Safeguard Clause” gives each of the Member States the juice to force bad devices from the market. Trust the doctor when I say, “IVD medical device manufacturers that fail to act quickly in regards to addressing issues associated with bad devices, will be on the receiving end of the splenetic (look-it-up) tone coming from each of the Member States from their respective Competent Authorities.”
The IVDD – 98/79/EC
Article 8 – Safeguard Clause
1. Where a Member State ascertains that the devices referred to in Article 4(1), when correctly installed, maintained and used for their intended purpose may compromise the health and/or safety of patients, users or, where applicable, other persons, or the safety of property, it shall take all appropriate interim measures to withdraw such devices from the market or prohibit or restrict their being placed on the market or put into service. The Member State shall immediately inform the Commission of any such measures, indicating the reasons for its decision and, in particular, whether non-compliance with this Directive is due to:
(a) failure to meet the essential requirements referred to in Article 3;(b) incorrect application of the standards referred to in Article 5, insofar as it is claimed that the standards have been applied;(c) shortcomings in the standards themselves.
2. The Commission shall enter into consultation with the parties concerned as soon as possible. Where, after such consultation, the Commission finds that:
– the measures are justified, it shall immediately so inform the Member State which took the initiative and the other Member States; where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the parties concerned, bring the matter before the committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the procedures referred to in Article 6; where the measure referred to in paragraph 1 is attributed to problems related to the contents or to the application of the common technical specifications, the Commission shall, after consulting the parties concerned, bring the matter before the Committee referred to in Article 7(1) within two months,– the measures are unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorized representative.
3. Where a non-complying device bears the CE marking, the competent Member State shall take appropriate action against whomsoever affixed the marking and shall inform the Commission and the other Member States thereof.4. The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure.
What IVD device manufacturers need to know
The entire process of regulatory pain commences when a Member State or States has ascertained that an IVD medical device is not performing as expected. Once the vigilance reports start flowing, problems with a device quickly become apparent. In fact, when the calls from the Competent Authorities and your notified bodies start flooding the phone system, you just might be in for some significant regulatory headaches. In accordance with Article 8 of the IVDD, once a problem has been identified, the Member State is required to notify the Commission. The Member State must provide the Commission with the reasons and rationales supporting their decision to withdraw, prohibit, or restrict an IVD medical device’s presence on the European Market. Additionally, Member States must be very specific in regards to their decision and determine if the cause of the non-conformance is premised on:
1. A device’s failure to meet its essential requirements;2. The application of an incorrect standard ; and/or3. Actual problems “shortcomings” with the standard applied.
Once the proverbial “ball starts rolling” The Commission will enter into a consultation with all parties concerned in the hopes of obtaining a resolution to the issue at hand. The issue at hand being the removal, restriction, or prevention, of an IVD medical device, that is hurting patients and users while employed in its intended use, from being on the market in the EU. If it has been determined the issue is rooted in a problem with a specific standard or a common technical specification – CTS – (a rare event indeed), the Commission is required to bring the issue to the Committee (Article 6 of the IVDD) within two (2) months. However, if the Commission deems a Member State has unjustly acted, the Commission is required to notify the Member State of their decision to rescind the Member State’s action. Ultimately the manufacturer and/or the Authorized European Representative will be notified of the Commission’s final decision.
Finally, when it has been determined that a non-complying device still has the CE marking of conformity affixed, the Member State is required to pursue an appropriate course of action to ensure the CE mark is removed. The process of CE mark removal is eloquently simple. The notified body will contact an IVD medical device manufacturer’s Chief Jailable Officer (CJO) and politely state, “Take that the CE mark off the offending product now.” Can you say interruption of the supply chain? By the way, regulatory bodies have a way of sharing information. The chances are pretty good that if devices are hurting folks in the EU; MHLW, Health Canada, and of course your friends at the FDA are probably aware of the problem. Ouch!
What IVD device manufacturers need to do
The best device the doctor can possibly offer is that when a Member State has determined your organization’s products are hurting people, you need to act immediately. Dr. D recommends putting a cross-functional-team together that is capable of collecting and analyzing information quickly. In fact, the CJO should be the point person on this team. That being said, the chances are pretty darn good that a recall will be one of the outcomes. Crisis management tools should be employed. Ensure your authorized representative, notified body, the Competent Authorities, and most important the customers are identified as key stakeholders in the process. If possible, it is always preferred to have replacement product available, if the safety and efficacy issue is not rooted in the actual design. If that is not possible, and you may think the doctor is completely bonkers, but the ethical thing to do is point customers in the direction of a competitor to fill the void resulting from a market withdraw. Yes, there is risk pursuing this approach; however, the best interests of the patient and user must always be considered first.
On the flip-side of the argument, there is a possibility the device problem is actually premised on a standard or CTS. If this happens to be the case, this is a golden opportunity to engage the Competent Authorities and provide potential solutions for the standard or CTS issue. Are the Competent Authorities, Commission, or Committee on Standards actually going to listen to the input and constructive feedback provided by the manufacturer? Maybe; however, offering to provide assistance is a nice way to ensure your organization is placed into a positive light after a period of turmoil.
Takeaways
At the end of the day, IVD medical devices are expected to be safe and effective in their intended use. If a Member State determines that a device is causing harm to the patient or user, under Article 8 of the IVDD, they are required to pursue action. These actions can include, (a) market withdraws (recall), (b) prohibited entry, or (c) restricted use. Pick one; however, all three choices are bad. The doctor’s choice is always (d) none of the above.
Until the next installment of DG, when Dr. D provides insight and guidance into complying with Article 9 (Conformity Assessment Procedures) of the In Vitro Diagnostic Medical Device Directive, a.k.a., IVDD – cheers from Dr. D and best wishes for continued professional success.
References:
- Council Directive 90/385/EEC. (1990, June). Council Directive 90/385/EEC on the approximation of the laws of Member States relating to active implantable medical devices. Retrieved November 15, 2011, from http://eur-lex.europa.eu
- 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.
- Devine, C. (2011). Devine Guidance series on complying with the MDD. Published in The Medical Device Summit.
- Directive 98/34/EC. (1998, June). Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 – laying down a procedure for the provision in the field of technical standards and regulations and of rules on information society services. Retrieved November 15, 2011, from http://eur-lex.europa.eu
- 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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