Devine Guidance

IVDD Annex IX

By Dr. Christopher Joseph Devine
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The relationship between the notified body and the device manufacturer is not unlike a marriage. If a positive relationship is garnered and sustained, life is beautiful. If the relationship sours, then divorce is inevitable; and then the phrase is; “I want my CE mark back, now!”

Annex IX (Criteria for the Designation of Notified Bodies) of the IVDD is all about the notified bodies. Similar to the rigors and levels of oversight the notified bodies provide for their clients, the device manufacturers; the Competent Authorities, from each of the Member States, provide the oversight for notified body compliance.

No doubt the device manufacturers are the primary source of revenue for the notified bodies; however, the primary source of grief for notified bodies comes from the Competent Authorities. Over the years, Dr. D has had the pleasure to work with many notified bodies and most are pretty reasonable and competent. BSI, SGS, TUV-SUD, TUV-R, DEKRA and NSAI (note: Dr. D is not a paid spokesperson for these organizations) are good examples of experienced notified bodies capable of helping device manufacturers navigate the European regulatory waters.

For device manufacturers that continue to remain ever recalcitrant (look-it-up) when it comes to complying with the IVDD or the other device Directives, Dr. D has an elementary phrase for you. “No CE marking of conformity equates to no revenue stream coming from the European Union (EU).” For device manufacturers wishing to enter the EU market, choose your notified bodies wisely. One point the doctor continues to make is that the relationship between the notified body and the device manufacturer is not unlike a marriage. If a positive relationship is garnered and sustained, life is beautiful. If the relationship sours, then divorce is inevitable. In a traditional marriage the cost is “1/2 plus.” In a divorce from the notified body, the phrase is; “I want my CE mark back, now!”  

The IVDD – 98/79/EC
Annex IX – Criteria for Designation of Notified Bodies 

1. The notified body, its director and the assessment and verification staff shall not be the designer, manufacturer, supplier, installer or user of the devices which they inspect, nor the authorized representative of any of these persons. They may not be directly involved in the design, construction, marketing or maintenance of the devices, nor represent the parties engaged in these activities. This in no way precludes the possibility of exchanges of technical information between the manufacturer and the body.

2. The notified body and its staff must carry out the assessment and verification operations with the highest degree of professional integrity and the requisite competence in the field of medical devices and must be free from all pressures and inducements, particularly financial, which might influence their judgment or the results of the inspection, especially from persons or groups of persons with an interest in the results of the verifications. Should the notified body subcontract specific tasks connected with the establishment and verification of the facts, it must first ensure that the subcontractor meets the provisions of the Directive. The notified body shall keep at the disposal of the national authorities the relevant documents assessing the subcontractor’s qualifications and the work carried out by the subcontractor under this Directive.

3. The notified body must be able to carry out all the tasks assigned to such bodies by one of Annexes III to VII and for which it has been notified, whether these tasks are carried out by the body itself or on its responsibility. In particular, it must have the necessary staff and possess the facilities needed to perform properly the technical and administrative tasks entailed in assessment and verification. This includes the availability of sufficient scientific staff within the organization who possess adequate experience and knowledge necessary to assess the biological and medical functionality and performance of devices for which it has been notified, in relation to the requirements of this Directive and, in particular, with Annex I requirements. The notified body must also have access to the equipment necessary for the verifications required.

4. The inspection staff must have:

— sound vocational training covering all the assessment and verification operations for which the body has been designated,

— satisfactory knowledge of the rules on the inspections which they carryout and adequate experience of such inspections,

— the ability required to draw up the certificates, records and reports to demonstrate that the inspections have been carried out.

5. The impartiality of the inspection staff must be guaranteed. Their remuneration must not depend on the number of inspections carried out, nor on the results of the inspections.

6. The body must take out civil liability insurance, unless liability is assumed by the State under domestic legislation or the Member State itself carries out the inspections directly.

7. The staff of the inspection body are bound to observe professional secrecy with regard to all information gained in the course of their duties (except vis-à-vis the competent administrative authorities of the State in which their activities are carried out) under this Directive or any provision of national law putting it into effect.

What IVDD medical device manufacturers need to know
The real beauty about Annex IX is that device manufacturers only need to know it exists. The seven sections/clauses associated with Annex IX pertain to the notified bodies and the salient requirements that are inherent in their day-to-day operating parameters required for compliance. The seven regulatory requirements required by Annex IX are:
  1. The notified body cannot design, manufacture, supply, or install the medical devices they are tasked with inspecting. This includes a provision for not doubling as the EU authorized representative.
  2. Notified bodies must be professional and competent when executing their duties. Who knew?
  3. Notified bodies are required to have an adequate facility and staff to perform assessment and verification activities.
  4. The inspection staff: (a) must be properly trained; (b) possess sufficient regulatory knowledge; and (c) the have the cognitive ability to create certificates, records, and reports.
  5. Notified bodies must be impartial.
  6. The notified body must retain a civil liability insurance policy.
  7. Notified bodies are required to respect device a manufacturer’s confidentiality. Can you say non-disclosure agreement?
What IVDD medical device manufacturers need to do
Not wanting to state the obvious but obliged to do so, the word that continues to come into Dr. D’s mind is “nothing.” Seriously, Annex IX is not targeted for device manufacturers, but there are a few things device manufacturers can do to assist in the nurturing of their relationship with their notified bodies. It starts with the design, development and manufacture of in vitro diagnostic devices that are safe and effective in their intended use. IVDDs must be capability of providing accurate and repeatable results. If device manufacturers really want to foster the relationship, they can invest adequate resources into sustaining a functional quality management system (QMS) that is in compliance with IVDD requirements. Besides, the doctor will let you in on a little secret here; compliance to the IVDD is actually mandated by law in the EU. Who knew?
Takeaways
Since Annex IX is targeting the notified bodies, the doctor will leave just one takeaway from this week’s guidance. Regardless of the European regulatory requirement: IVDD, MDD, or AIMDD compliance is mandatory. In fact, it really is a question of law in all of the 27 Member States. Failure to abide by the laws of the EU, such as full compliance with the IVDD, and a device manufacturer will be looking for alternate markets to sell their devices. One final thought from Dr. D; “There is no such thing as minimum compliance or maximum compliance to the IVDD, there is just compliance, period!”

Until the next installment of DG, when Dr. D provides insight and guidance into complying with Annex X (CE Marking of Conformity) of the In Vitro Diagnostic Medical Device Directive, a.k.a., IVDD – cheers from Dr. D and best wishes for continued professional success.

References: 

  1. 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
  2. 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.
  3. Devine, C. (2011). Devine guidance for complying with the European medical device directive – MDD. Charleston, SC: Amazon.
  4. Devine, C. (2012). Devine Guidance series on complying with the IVDD. Published in The Medical Device Summit
  5. 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 
  6. Retrieved September 12, 2011, from http://eur-lex.europa.eu

About The Author

Dr. Christopher Joseph Devine, President, Devine Guidance International

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