Article 14b, of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for “Particular Health Monitoring Measures.” Can you say market withdraw? The axiomatic (look-it-up) concept of withdrawing product from the European market equates to just one simple six-letter word, “RECALL.”
Article 14b, of the Directive, is all about Member States having the power to force products or groups of products off the market in support of preserving public health. Additionally, Article 14b gives Member States the power to block, restrict or subject to additional requirements, devices or groups of devices. Once a Member State had taken appropriate action to protect public health and safety within their own borders, the Member State must notify the Commission and other Member States in regards to action taken. The onus of making a decision is then placed squarely on the shoulders of the Commission. The Commission will consult with Member States and interested parties, e.g., device manufacturer(s) and decide if the action pursued by the Member State is justified.
Furthermore, when deemed necessary and appropriate, additional regulatory action can be pursued up to and including the amending of non-essential Directive elements influencing market withdraw and/or prohibiting introduction of products, so products can eventually enter the European Market. Finally, when all else fails the Commission has the authority to invoke Article 7(4), a.k.a. the urgency procedure.
The MDD – 93/42/EEC
Article 14b – Particular Health Monitoring Measures
Where a Member State considers, in relation to a given product or group of products, that, in order to ensure protection of health and safety and/or to ensure that public health requirements are observed, such products should be withdrawn from the market, or their placing on the market and putting into service should be prohibited, restricted or subjected to particular requirements, it may take any necessary and justified transitional measures. The Member State shall then inform the Commission and all other Member States, giving the reasons for its decision. The Commission shall, whenever possible, consult the interested Parties and the Member States. The Commission shall adopt its opinion, indicating whether the national measures are justified or not. The Commission shall inform all the Member States and the consulted interested Parties thereof. When appropriate, the necessary measures designed to amend nonessential elements of this Directive, relating to withdrawal from the market, prohibition of placing on the market and putting into service of a certain product or group of products or to restrictions or introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4).
What you need to know
Hopefully, as a device manufacturer, you will never face the dilemma of dealing with Article 14b. However, the device manufacturing industry is far from utopic; and that is why copious amounts of regulations exist. That said, just as in death and taxes, it is inevitable device manufacturers will suffer through a forced product withdraw or prohibition of market entry of devices into the EU.
On a positive note, that is why device manufacturers retain and pay dearly, their notified bodies. A competent notified body will help device manufactures navigate the sometimes turbulent waters of the European device market. As with all regulations arising from participation in multiple markets, the device manufacturer should have a through grasp and understanding of the applicable regulations.
In the support of this week’s guidance, Dr. D strongly suggests understanding the content of Article 14b and the potential impact the Article has on your business. Remember, forced-market withdraws, or a complete blockage of your devices from entering a Member State(s) equates to an interruption in the revenue stream. Simply stated, “Not making euros is a bad thing.” Yes, the doctor sounds like a capitalist; however, Dr. D is also a pragmatist and a realist.
What you need to do
Device manufacturers need to work closely with their notified bodies to ensure their business is never placed at risk with the Competent Authorities in the EU. Article 14b is very real in regards to Member States taking the appropriate action to protect public safety and health. Dr. D always recommends that device manufacturers ensure compliance to device essential requirements is always established.
This commences with a robust design and development process and continues through validation testing. A robust design should result in manufactured medical devices that are safe and effective. If a device is safe and effective, then Article 14b of the Directive will never be an issue for device manufacturers.
Takeaways
Device manufacturers should never attempt to ensconce (look-it-up) device problems in an effort to circumvent Article 14b. In fact, the EU is becoming much smarter in regards to collecting device data, especially for problem devices. Going back to last week’s edition of DG, the European Databank (EUDAMED) will be fully functional in 2012.
That said, there are two takeaways from this edition of DG. One – a robust design and development process will lead to medical devices that are safe and effective. Two – devices that are safe and effective; and meet their essential requirements, seldom if ever will run afoul of Article 14b of the MDD. In closing, use your notified body for guidance. They make a substantial amount of coin from their customers (you), so device manufacturers should ensure they get their money’s worth. Until the next installment of DG, when Dr. D will provide guidance for complying with Article 15 (Clinical Investigation) of Council Directive 93/42/EEC, the MDD – cheers from Dr. D and best wishes for continued professional success.
References:
- Council Directive 93/42/EEC. (1993, June). Council Directive 93/42/EEC concerning medical devices. Retrieved December 21, 2010, 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.
- EUDAMED. (2010, June). European databank on medical devices. Retrieved April 25, 2011, from http://ec.europa.eu/consumers/sectors/medical-devices/market-surveillance-vigilance/eudamed/
Related Articles
-
The new guidance is intended to establish confidence in automation used for production or quality assurance systems and describe various methods and testing activities that may be applied to establish computer software assurance and meet regulatory software validation requirements.
-
The updated guidance document clarifies what constitutes a statement of the basis for the deficiency and includes examples of well-constructed deficiencies and industry responses to facilitate a more efficient review process.
-
The revised cybersecurity draft publication is not intended to be a checklist for healthcare organizations to follow, but rather a guide to help them comply with the HIPAA Security Rule.
-
The draft guidance proposes updates to clarify how the Breakthrough Devices Program may be applicable to certain medical devices that promote health equity, as well as considerations in designating eligible devices that may benefit populations impacted by disparities in health…
