Article 15 (Notified Bodies) of the IVDD (98/79/EC) delineates the basic requirements governing the qualification of notified bodies within the European Union (EU). As the readers of Devine Guidance are all very much aware, the notified bodies are in a fairly precarious position. On one hand, they receive their authority from the Competent Authority located in the Member State in which the call home. However, on the other hand, they work for you, the device manufacturers. Remember, you pay them handsome sums of money for their support and the rental of their CE Mark. If you don’t believe Dr. D, just ask the finance person tasked with writing and signing the checks before they are mailed to your notified body.
Being a self-appointed rapporteur (look-it-up) tasked with reporting on the virtues and nuances of the IVDD, while providing a no-nonsense approach for achieving compliance, Dr. D, on occasion, has made the notified bodies a target of my humor. That being said, make no mistake, the notified bodies are the most important player (my opinion) in the quest for device manufacturers to successfully introduce IVDDs into commerce in the EU. After all, they are paid to: (a) assess, and hopefully approve, a device manufacturer’s Quality Management System (QMS); (b) review, and hopefully approve, device applications; (c) issue quality system and design examination certificates; and (d) authorize the affixing of their CE Mark onto approved products heading into the EU.
One final point, before the doctor dives into this week’s guidance, device manufacturers should choose wisely when looking for a notified body. Broken-record time folks, remember the relationship between a device manufacturer and their notified body should be treated as a marriage. Why? Because simply put, divorces can be quite messy, especially in California where the result is often half-plus some more. Divorcing your notified body can be equally messy and expensive, especially if a significant number of devices are involved. The costs associated with making changes to packaging, labeling, Instructions for Use, and all of the regulatory notifications required, quickly escalate into the realm of real expensive, so “choose wisely!”
The IVDD – 98/79/EC
Article 15 – Notified Bodies
1. Member States shall notify the Commission and other Member States of the bodies which they have designated for carrying out the tasks pertaining to the procedures referred to in Article 9 and the specific tasks for which the bodies have been designated. The Commission shall assign identification numbers to these bodies, hereinafter referred to as ‘notified bodies.’The Commission shall publish a list of the notified bodies, together with the identification numbers it has allocated to them and the tasks for which they have been notified, in the Official Journal of the European Communities. It shall ensure that the list is kept up to date.Member States shall not be obliged to designate a notified body.2. Member States shall apply the criteria set out in Annex IX for the designation of bodies. Bodies that meet the criteria laid down in the national standards which transpose the relevant harmonized standards shall be presumed to meet the relevant criteria.3. Member States shall apply continual surveillance of notified bodies to ensure ongoing compliance with the criteria set out in Annex IX. A Member State that has notified a body shall withdraw or restrict that notification if it finds that the body no longer meets the criteria referred to in Annex IX. It shall immediately inform the other Member States and the Commission of any withdrawal of notification or any restriction placed on it.4. The notified body and the manufacturer, or his authorized representative established in the Community, shall lay down, by common accord, the time limits for completion of the assessment and verification operations referred to in Annexes III to VII.5. The notified body shall inform the other notified bodies and the competent authority about all certificates suspended or withdrawn and, on request, about certificates issued or refused. It shall also make available, on request, all additional relevant information.6. Where a notified body finds that pertinent requirements of this Directive have not been met or are no longer met by the manufacturer or where a certificate should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or place any restrictions on it unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer. In the case of suspension or withdrawal of the certificate or of any restriction placed on it or in cases where an intervention of the competent authority may become necessary, the notified body shall inform its competent authority thereof. The Member State shall inform the other Member States and the Commission.7. The notified body shall, on request, supply all relevant information and documents, including budgetary documents, required to enable the Member State to verify compliance with Annex IX requirements.
What IVDD medical device manufacturers need to know
As stated in the introduction of this week’s guidance, notified bodies receive their power and authority from the Competent Authorities located in the Member State from which they operate. The Commission is tasked with issuing a unique registration number for each of the notified bodies. For example, TUV-Rhineland has been assigned 0197 as their registration number. If TUV is your notified body, CE 0197 should be prominently affixed to your product packaging. The Commission is also tasked with maintaining a compiled list of approved notified bodies; and the publishing of this list into the Official Journal of the European Communities.
Similar to the oversight, sometimes painful, the notified bodies are required to exercise over their clients (device manufacturers), Competent Authorities are required to exercise oversight over their notified bodies. In fact, notified bodies failing to meet the criteria defined within Annex IX of the IVDD will soon find themselves on the receiving end of the wrath of the Competent Authorities. The wrath could be restrictions being placed on a notified body or even worse, the actual withdraw of their authority (removal of their name from the book of life – a.k.a. the Official Journal); either way, these are bad things.
On a positive note, device manufacturers or their EU Authorized Representatives can work with their notified bodies and agree upon: (a) a timetable for the completion of applicable assessments or the completion of verification activities associated with preparing technical documentation needed to support the device application process; and (b) the assessment of the QMS. On a not-so-positive note, the notified body can giveth and the notified body can taketh away certificates associated with the QMS or product approvals (a.k.a. design examination certificates). To make matters worse, the notified bodies are required to inform other notified bodies of all certificates withdrawn, suspended, or refused.
Additionally, if a notified body has ascertained that a device manufacturer no longer meets the criteria prescribed within the IVDD or makes a determination that a certificate should never have been issued, after explaining to the Competent Authority as to how this error could have occurred, they are required to suspend, withdraw, or if a device manufacturer is lucky, place restrictions on the certificate issued. If the device manufacturer reacts quickly, with appropriate corrective action to remedy compliance issues, then restrictions may be in order. However, for major deviations, the doctor is pretty sure a device manufacturer will be rapidly removing CE Marks from their product packaging.
Regardless, all bets are off. If involvement from the Competent Authority is required to remedy compliance concerns (upon request of the notified body), then Member States are required to notify other Member States and the Commission. Before long, the entire EU regulatory world knows that a certain device manufacturer has compliance issues. If these same devices are sold within the United States, it is just a matter of time before these compliance issues result in a “Big Hello, FDA!”
What IVDD medical device manufacturers need not to do
Instead of informing device manufacturers of what you need to do to comply with Article 15, Dr. D will provided a list of 10 things not to do, so the negative connotations associated with Article 15 will never be an issue. If you do not like the doctor’s list, I am quite sure you experienced RA and QA types can come up with a list of your own.
- Do not fail to comply with the requirements delineated with the IVDD.
- Do not do a poor job in executing testing to establish compliance with essential requirements.
- Do not refuse to employ harmonized standards.
- Do not fail to maintain technical files and design dossiers in an ongoing state of compliance.
- Do not fail to retain adequate resources to support a compliant QMS.
- Do not fail in the application of an effective post-market surveillance system.
- Do not fail to file or investigate (root-cause please) vigilance reports.
- Do not wrongly affix a CE Mark to their product.
- Do not fail to remove a CE Mark when ordered to do so by your notified body.
- Do not fail to pay your notified body for services rendered (the doctor hopes this one is self-explanatory). If any of my friends from the network of notified bodies is reading this week’s DG, you are welcome.
Takeaways
The takeaway from this edition of DG is pretty simple. In reality, it comes down to two words, “oversight and compliance.” Notified bodies are tasked with providing oversight of their clients (device manufacturers) to ensure compliance to the IVDD, or any applicable Directive, is maintained. The Competent Authorities are tasked with providing oversight of their notified bodies to ensure compliance to the IVDD, or any applicable Directive is maintained. Failure of a notified body or a device manufacturer to maintain compliance with the IVDD, or the other two Directives, will result in sanctions, which can include the withdrawing of certificates issued to device manufacturers (no CE Mark); or the removal of authority granted to notified bodies (removal from the list). Either way, failing to comply is always a bad thing. I do not think Dr. D can make it any simpler to understand other than stating, “No CE Mark equates to no revenue stream coming from the EU.
Until the next installment of DG, when Dr. D provides insight and guidance into complying with Article 16 (CE Marking) of the In Vitro Diagnostic Medical Device Directive, a.k.a., IVDD – cheers from Dr. D and best wishes for continued professional success.
References:
- 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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