IVDD – Article 4
Article 4 (Free Movement) of the IVDD (98/79/EC), is very close in construction to Article 4 of the MDD minus the special purposes. Under a signed agreement between President Obama and the Commission, all medical devices shipped from the United States into the European Economic Community (EEC) can ship for free; henceforth the title, “Free Movement.” Ha, Ha, Ha, I hope the readers realize (with a z) that Dr. D is just having some fun and no such agreement exists.
That being said, I wanted to begin this week’s guidance by sharing an email I received from a friend of mine from Galway, Ireland. He has been reading Devine Guidance diligently for the past-two years and he loves the content, except for one minor issue. He asked me why I continue to spell some words in the Directives incorrectly. In fact, this is not the first time Dr. D has been chastised for employing American English versus the Irish or UK version. I do apologize (with a z) for every time the doctor changes the spelling of “authorised” to “authorized.” However, I have searched the Merriam-Webster’s Dictionary diligently and cannot seem to find the word “sebra” that black and white-striped horse found on the Serengeti or in most zoos. Week after week, the doctor continues to provide Dr. Disms, a bad habit of catachresis (look-it-up); however, I hope my subtle comparisons to make a point are helpful to the reader.
The IVDD – 98/79/EC
Article 4 – Free Movement
1. Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices bearing the CE marking provided for in Article 16 if these devices have undergone conformity assessment in accordance with Article 9.2. Member States shall not create any obstacle to devices intended for performance evaluation being made available for that purpose to the laboratories or other institutions listed in the statement referred to in Annex VIII if they meet the conditions laid down in Article 9(4) and Annex VIII.3. At trade fairs, exhibitions, demonstrations, scientific or technical gatherings, etc. Member States shall not create any obstacle to the showing of devices which do not conform to this Directive, provided that such devices are not used on specimens taken from the participants and that a visible sign clearly indicates that such devices cannot be marketed or put into service until they have been made to comply.4. Member States may require the information to be supplied pursuant to Annex I, part B, section 8 to be in their official language(s) when a device reaches the final user. Provided that safe and correct use of the device is ensured, Member States may authorize the information referred to in the first subparagraph to be in one or more other official Community language(s).In the application of this provision, Member States shall take into account the principle of proportionality and, in particular:
(a) whether the information can be supplied by harmonized symbols or recognized codes or other measures;(b) the type of user anticipated for the device.
5. Where the devices are subject to other directives concerning other aspects which also provide for the affixing of the CE marking, the latter shall indicate that the devices also fulfill the provisions of the other directives.However, should one or more of these directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate that the devices fulfill the provisions only of those directives applied by the manufacturer. In this case, the particulars of these directives, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions required by the directives and accompanying such devices.
What IVD device manufacturers need to know
Article 4 of the IVDD is basically broken down into five clauses that are fairly easy to comprehend. Remember the goal of the Directive is not to prevent IVD medical devices that are safe and effective from entering into commerce within the EU. The salient objective of the Directive is to establish guidelines for facilitating the movement of IVD medical device that are safe and effective into the EU. That being said, Dr. D categorizes (with a z) the five requirements of Article 4 as:
- Member States shall not block the entry of devices that contain a legally affixed CE Mark;
- Member States shall not block the entry of devices being used for performance evaluation;
- Member States shall not block the entry of non-CE marked devices to be used as samples only (not for human use);
- Member States can require device labeling and Instructions for Use (IFU) be provided in their native tongue; and
- When applicable, devices that fall under the jurisdiction of multiple Directives must comply with the appropriate Articles and Annexes of these Directives prior to the affixing of a CE Mark.
See, the doctor said the requirements for Article 4 were pretty simple to understand; however, implementation, well that is another story. I think the need for an IVD medical device to have a CE mark affixed to the outer-most packaging is a universally understood concept. Dr. D also believes shipping devices into the EU for evaluation and testing is also a universally understood concept; however, understanding the language requirement and the impact on individual Member States, not so much. A point that Dr. D made in his previous series of articles on the MDD pertained to the use of English as the international language. Years ago (circa 1960’s) there was an obscure UN resolution to make English the Universal language versus French. Of course the French protested vehemently and the revised agreement recognized (with a z), I believe, five additional languages.
Unfortunately, in today’s regulatory environment, every single country wants device labeling and Instructions for Use (IFU) in the native language. The doctor is an old guy and remembers when employing English only was basically accepted. Then the requirement changed to English plus five additional languages, followed by English plus 10. Where does it all end or is there even an end in sight? The bad news is that device manufactures have run out of label space and IFUs have turned into books. The good news is print on-demand is alive and well. However, print on-demand can also be that double-edged sword, if proper controls are not maintained. God forbid if devices packaged with an IFU printed in Spanish, ended up in the hands of a Polish physician. Dr. D believes that there would be some explaining to do with the notified body and potentially the Polish Competent Authority, if such errors prompted a “Recall” (one of the doctor’s favorite six-letter words).
What IVD device manufacturers need to do
Folks, the requirements delineated within Article 4 of the IVDD (my opinion) clearly fall into the “no-brainer category” in regards to compliance. As Dr. D has already stated, having a CE mark affixed to product packaging is a salient requirement of the Directive. Simply stated, “No CE mark, no shipments into Europe.” That being said, IVD medical device manufacturers must ensure all of their products have applications and technical data that have been reviewed and approved by their notified body. Trust me; you will know when the approval has been issued. Why, because written notification will be provided by your notified body.
Dr. D also believes the language requirement also falls into the no-brainer category. Each Member State has the legal right to receive devices with labeling and IFUs in their native tongue. The bottom line is that this simple fact is the law in the EU.
As for shipping non-CE mark devices for samples or IVD medical devices for test and evaluation, the doctor suggests that device manufacturers work with their notified body. The notified bodies that device manufacturers pay dearly to retain can help facilitate the smooth entry, of products falling into this category, into the EU. Obviously, they will not handle the actual shipping for device manufacturers, but they can ensure the required documents and notifications are properly prepared.
Takeaways
For this edition of DG, Dr. D will leave the readers with just two really important takeaways. One – having an IVD medical device that is safe and effective is important; however, without a CE mark, the device cannot enter into commerce in the EEC. Two – the language requirement will continue to be one of the biggest challenges for device manufacturers as more countries opt to have labeling and IFUs in their native tongues. Regardless of what the rest of the world wishes for, having an IVD medical device labeled and packaged with an IFU in a Member State’s native tongue is a salient requirement under Article 4 of the IVDD.
Until the next installment of DG, when Dr. D provides insight and guidance into complying with Article 5 (Reference to Standards) 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 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
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…
