Article 8, of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for the “Safeguard Clause.” Can you say “Recall?” For frequent readers of Devine Guidance (DG), “Recall” is that nasty six-letter word that Dr. D invokes from time to time, versus “market withdrawal,” a term that is often perceived as a kinder and gentler version of the device-removal process.
Regardless, Article 8 of the Directive is all about the removal of devices from Member States when violations of the Directive occur (e.g., failure to meet essential requirements, incorrect application of a standard, or any identified shortcoming with a standard) or when devices pose a potential threat to patient health and safety. As always, Dr. D hopes the readers understand my position of preaching compliance and are not just attitudinizing (look-it up) for my benefit.
The MDD – 93/42/EEC
Article 8 – Safeguard Clause
1. Where a Member State ascertains that the devices referred to in Article 4 (1) and (2) second indent, 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, 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, in so far 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:
(a) The measures are justified:
(i) It shall immediately so inform the Member State which took the measures 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 advisory procedure referred to in Article 6(2);
(ii) When necessary in the interests of public health, appropriate measures designed to amend non-essential elements of this Directive relating to withdrawal from the market of device referred to in paragraph 1 or to prohibition or restriction of their placement on the market or being put into service or to 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 Article7 (4); (b) the measures are unjustified, it shall immediately so inform the Member State which took the measures 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 has affixed the mark 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 you need to know
The first requirement, inferred by Article 8, that device manufacturers need to know is that when a Member State determines a device poses a risk to public health and safety, the Member State shall take all of the appropriate steps to ensure the offending device is withdrawn (RECALL – yes Dr. D loves throwing that word around). This includes ensuring the necessary steps are taken to restrict or prevent market access for non-compliant devices.
The second thing that device manufacturers need to know is that recalls are expensive (duh, duh-duh – thank you Carlos Mencia) and the offending manufacturer can expect to take a significant hit on their profits as revenue streams are suddenly interrupted. Additionally, the Member State identifying the device/compliance issue shall notify the Commission in regards to market withdraws, supported by the data and logic driving their decision-making process. Furthermore, a device’s failure to meet its essential requirements, a device manufacturer’s incorrect application of standards, and/or issues with the standards themselves are all valid reasons for withdraw and the prevention of offending devices from entering or remaining on the European market.
The second requirement device manufacturers need to know is that the Commission will consult with the appropriate parties and make a determination on the validity of the decisions made by Member States. For example, if the actions pursued by a Member State are deemed to be justified, the Commission is tasked with notifying other Member States of the decisions made and actions pursued. If the root cause of an issue is actually standards related, the Commission will refer the issue to the Committee tasked with oversight of the standard(s) for resolution.
The third requirement device manufacturers need to know is that an urgency procedure exists for expediting the notification of all Member States; and the subsequent removal of devices deemed to pose a serious threat to patient health and safety. Once again, can you say “Recall?”
The final requirement, that device manufactures need to know, relates to the affixing of the CE Mark to products. If a device manufacturer has been notified of a device issue, resulting in the withdraw of product from the European market, the expectation is that the CE Mark be removed from the product – ASAP! Trust Dr. D when I say, “The competent authorities will make the lives of notified bodies miserable if a CE Mark, containing their registration number, is affixed to offending devices.” This requirement is pretty cut and dry. If the device does not meet essential requirements, and perform as advertized in regards to intended use, the CE Mark shall be removed – period! If the CE Mark is not removed, Article 8 of the Directive gives Member States the power and authority to pursue regulatory action against the offending device manufacturer.
What you need to do
Not wanting to state the obvious but obliged to do so, device manufacturers must ensure that devices are robust in their design and performance. For Europe, that includes meeting the essential requirements appropriate for the device’s classification and intended use. One thing to keep in mind, the EU does have a reporting requirement for devices that cause patient injury or death. MEDDEV 2.12 rev 5 (Guidelines on a Medical Devices Vigilance System) makes for some interesting reading.
Additionally, the EU now has a database for capturing Vigilance Reporting Data (Medical Devices Sector – Implementation Vigilance Competent Authorities Notification Reports). Now more than ever, it becomes almost impossible for problem devices to be confined to just one Member State. Furthermore, if a device manufacturer’s notified body informs them that a CE Mark must be removed from products; they must move quickly to remove the CE Mark with the highest sense of urgency. Why? Because failure to do so can result in a device manufacturer’s entire product portfolio being blocked from entry into the EU or other markets that require compliance with European essential requirements, e.g., Canada, Australia, etc.
Takeaways
The takeaways from this edition of DG are pretty basic. One, device manufacturers must be prepared to withdraw their devices from the European Market if the devices pose a risk to patient health and safety. Two, device manufacturers must remove all CE Marks affixed to offending product “ASAP” when asked to do so by their notified body. Remember, the Competent Authorities will be watching. Finally, just a watch out, the EU is getting much better at collecting and organizing vigilance reporting data. That said, device manufacturers are expected to react quickly when their devices have been identified as posing a threat to public health and safety within the EU.
Until the next installment of DG, when Dr. D will provide guidance for complying with Article 9 (Classification) 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.
-
MEDEV 2.12-1 rev 5. (2007, April). Guidelines on a medical devices vigilance system. European Commission DG Enterprise and Industry. Retrieved February 26, 2011, from www.gtlaw.com/portalresource/lookup/wosid/contentpilot
-
Vigilance Reports. (2011, February). Europa.en Website. Retrieved February 26, 2011, from http://ec.europa.eu/consumers/sectors/medical-devices/documents/vigilance-reports/index_en.htm
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 UK MHRA has published “Software and Artificial Intelligence as a Medical Device.” The guidance document assembles previous guidances and regulatory requirements for SaMD and AIaMD devices seeking commercialization in the UK market.
-
The guidance is intended to clarify the FDA’s approach for referencing the terms “device” and “counterfeit device” in FDA documents, as well as how the agency intends to interpret existing references to section 201(h) of the FD&C Act in guidance,…
-
“Addressing unmet needs across pediatric populations is critical to advancing children’s health, and we are delighted to once again work with pioneering companies that seek to bridge this care gap."
