As I finish out the year with this edition of Devine Guidance, I want to personally thank all of the readers who week-after-week have continued to read Dr. D’s diatribes about quality and regulatory compliance. I really hope you enjoy reading these articles as much as I enjoy writing them; and you are finding value in the guidance provided. That being said, I wish each of you a safe and joyous holiday season and a safe and prosperous 2012. Thank you for reading.
Article 11 (Vigilance Procedure) of the IVDD (98/79/EC), is all about problem devices. In short, if an IVDD device is deemed not safe and effective, and is hurting the patient and/or user, when employed in the device’s intended use, the European Vigilance Procedure kicks into high gear.
Since the holiday season is upon us, Dr. D would like to use some festive lyrics from an old Christmas song: “You better not shout, you better not pout, you better not cry, Dr. D is telling you why, the Competent Authorities are coming to town.”
Yes, the doctor knows, stick to writing, but the point I am making is that the Member States, through their Competent Authorities, take swift action when bad devices do bad things to patients and users; and that my friends you can take to the bank. Speaking of banks, in the last edition of DG, Dr. D mentioned the fact that the European databank (Eudamed) is now live. This gives the regulatory authorities in the EU a very powerful tool for quickly tracking and identifying problem devices. Remember, the road to perdition (look-it-up) has always been paved with good intentions; however, there is a special place in regulatory Hades for IVDD manufacturers that ignore or fail to play by the rules of the IVDD and ship bad product into Europe.
The IVDD – 98/79/EC
Article 11 – Vigilance Procedure
1. Member States shall take the necessary steps to ensure that any information brought to their knowledge, in accordance with the provisions of this Directive, regarding the incidents mentioned below involving devices bearing the CE marking is recorded and evaluated centrally:
(a) any malfunction, failure or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health;(b) any technical or medical reason in relation to the characteristics or performance of a device for the reasons referred to in subparagraph (a), leading to systematic recall of devices of the same type by the manufacturer.
2. Where a Member State requires medical practitioners, the medical institutions or the organizers of external quality assessment schemes to inform the competent authorities of any incidents referred to in paragraph 1, it shall take the necessary steps to ensure that the manufacturer of the device concerned, or his authorized representative, is also informed of the incident.3. After carrying out an assessment, if possible together with the manufacturer, Member States shall, without prejudice to Article 8, immediately inform the Commission and the other Member States of the incidents referred to in paragraph 1 for which appropriate measures, including possible withdrawal, have been taken or are contemplated.4. Where, in the context of notification referred to in Article 10, a device notified, bearing the CE marking, is a ‘new’ product, the manufacturer shall indicate this fact on his notification. The competent authority so notified may at any time within the following two years and on justified grounds, require the manufacturer to submit a report relating to the experience gained with the device subsequent to its being placed on the market.5. Member States shall on request inform the other Member States of the details referred to in paragraphs 1 to 4. The procedures implementing this Article shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).
What IVD medical device manufacturers need to know
The salient concept associated with Article 11 pertains to the identification and subsequent notification of all parties concerned, when IVDD devices:
1. Malfunction;2. Fail in their intended use;3. Have a deterioration in their characteristics; or4. Problems with device labeling and/or instructions for use which led to or may result in the injury or death of a patient or user (directly or indirectly) must be reported.
Additionally, when the physicians (medical practitioners) are required to report information delineated in the bullet points above to the Competent Authorities, the competent authorities must notify the IVDD manufacturer and/or the manufacturer’s European authorized representative.
An assessment of the device issue must be performed (root-cause analysis baby); and once completed, the Member State affected by the problem device must notify the commission and other Member States of the recommended actions proposed. Can you say “RECALL?” Sorry, Dr. D knows the politically correct term is, “market withdraw,” but hey, the doctor has never been known to be politically correct.
Finally, if the IVDD device is newly entered into the European market; and vigilance reports are stacking up faster than pancakes at an all-you-can-eat breakfast buffet, rest-assured the Member States will quickly become involved and take the appropriate action. The reason Dr. D has separated out the term “New” is because the manufacturer is required to note the term “New” on any notification when a device is new to the EU. Who knew? The Competent Authorities will retain the right, for a two-year period, to have the manufacturer submit reports relating to the experience and knowledge garnered from having this “New” device on the market.
What IVD medical device manufacturers need to do
From the doctor’s standpoint, in a perfect world, IVDD manufacturers simply need to manufacture devices that are safe and effective for their intended use. Simply stated; “No vigilance reports equates to no worries.” Obviously, the device industry will never be perfect and continues to operate in a less then utopian environment. That being said, when problems with devices arise, the key is to work quickly through your notified bodies (remember you pay them for their help and support) and work with the Competent Authorities to address all issues associated with problem devices. I know the doctor likes to through around the use of the term recall; however, if a market-withdraw is the right decision, do not delay in execution. It is Dr. D’s strong opinion, “Diagnostic devices should never be hurting people, period.”
Takeaways
There really is just one takeaway from this edition of DG. If an IVDD manufacturer designs develops, and manufactures IVDDs that are safe and effective, then incidents of vigilance reporting will be few and far between.
Until the next installment of DG (January 4, 2012), when Dr. D provides insight and guidance into complying with Article 12 (European Databank) of the In Vitro Diagnostic Medical Device Directive, a.k.a., IVDD – cheers from Dr. D and best wishes for continued professional success.
References:
- Commission Decision 2010/227/EU. (2010, April). Commission decision of 19 April 2010 on the European Databank on Medical Devices (Eudamed). Retrieved December 9, 2011, from http://eur-lex.europa.eu.
- 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.
- Devine, C. (2011). Devine Guidance series on complying with the MDD. Published in The Medical Device Summit.
- 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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