Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

IVDD Annex II

By Dr. Christopher Joseph Devine
Dr. Christopher Joseph Devine, President, Devine Guidance International

Annex II of the IVDD is critical as it ultimately drives the path for establishing and complying with essential requirements, and hopefully, the eventual approval from your notified body. And significant changes to Annex II are coming.

 

Annex II (List of Devices Referred to in Article 9(2) and (3)) of the IVDD (98/79/EC) delineates the actual list of devices covered by this Directive, premised on risk. If only the MDD (93/42/EEC) could be so simple. For those of you familiar with the IVDD, you already know that the Annex II is critical as it ultimately drives the path for establishing and complying with essential requirements; and hopefully, the eventual approval from your notified body.

For example, if a device falls under List A (high-risk devices), Dr. D strongly recommends commencing with the dossier assembly process. If a device falls under List B (lower-risk device), now would not be the time to breathe that proverbial sigh of relief. In fact, now would be a good time to start working on the technical file. For those of you that read the doctor’s hebdomadal (look-it-up) guidance, Dr. D would never lead you astray.

That being said, the next statement I am going to make should be considered mission critical for the manufacturers of IVDDs. Significant changes to Annex II are coming. A planned amendment to Annex II will result in the addition of two new lists (List C and List D). Additionally, List D will become the high-risk category versus List A, which will become the low-risk category. The best advice the doctor can give to device manufacturers is to start your preparations now. Why? Because Dr. D believes there is no time like the present.

The IVDD – 98/79/EC
Annex II – List of Devices Referred to in Article 9(2) and (3) 

 

A. GENERAL REQUIREMENTS
List A
— Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: ABO system, rhesus (C, c, D, E, e) anti-Kell; 
— reagents and reagent products, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B, C and D.
 
List B
— Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: anti-Duffy and anti-Kidd,
— reagents and reagent products, including related calibrators and control materials, for determining irregular anti-erythrocytic antibodies,
— reagents and reagent products, including related calibrators and control materials, for the detection and quantification in human samples of the
following congenital infections: rubella, toxoplasmosis,
— reagents and reagent products, including related calibrators and control materials, for diagnosing the following hereditary disease: phenylketonuria,
— reagents and reagent products, including related calibrators and control materials, for determining the following human infections: cytomegalovirus,
chlamydia,
— reagents and reagent products, including related calibrators and control materials, for determining the following HLA tissue groups: DR, A, B,
— reagents and reagent products, including related calibrators and control materials, for determining the following tumoral marker: PSA,
— reagents and reagent products, including related calibrators, control materials and software, designed specifically for evaluating the risk of trisomy 21, and
— the following device for self-diagnosis, including its related calibrators and control materials: device for the measurement of blood sugar.
 
What IVDD medical device manufacturers need to know
Inclusion of device categories into Annex II, List A or List B, are premised on risk. Unfortunately, device manufacturers do not have the authority to determine the risk category associated with their devices, and must adhere to Annex II. In reality, the overall IVDD process is pretty straight forward, once the correct category has been ascertained, premised on the employment of List A and List B.
  1. Select the appropriate category (List A versus List B).
  2. Define and establish compliance with essential requirements.
  3. Establish an effective post-market surveillance system.
  4. Have the Chief Jailable Officer (CJO) prepare and sign the Declaration of Conformity (DoC) – Extremely Important.
  5. Send the device application to your notified body.
  6. Once device approval is received, affix your notified body’s CE mark of registration to the product packaging.
  7. Commence with shipping product into the European Union (EU).
Obviously, there is much more involved, but device manufacturers that grasp these seven salient points are clearly ahead of their competition.
What IVDD medical device manufacturers need to do 
Before you scream at the doctor for providing an over-simplification of the process in the previous section, please recognize that Dr. D has only provided a few of the salient points. Additionally, Dr. D does understand that there is never a guarantee that the device application process will go smoothly. In fact, the notified bodies (remember – they work for you) should be guiding their clients through the entire process. When in doubt, ask your notified body for guidance (remember – you pay them).

That being said, all a device manufacturer has to do, in regards to Annex II, is to select the correct device classification, premised on List A or List B. Simply stated, there are currently two choices, List A or List B. If an IVDD device manufacturer fails to comprehend the employment of lists, then they can flip a coin and still have a 50-50 chance of getting it right. Dr. D is just kidding; please do not flip a coin. If a device manufacturer is unsure of classification, pick up the phone and call your notified body. If the notified body charges you for the call, find another notified body (there are several good ones to choose from). 

Takeaways
The takeaways from this week’s DG are eloquently simple. (1) Annex II categorizes devices premised on risk. List A is the high-risk category versus List B, the lower-risk category. (2) A planned amendment to the IVDD will result in the addition of two new lists, List C and List D. When implemented, List D will become the high-risk category versus List A as being the lowest-risk category. (3) The entire process commences with the selection of the correct device classification (List A versus List B). When in doubt, contact your notified body, remember – they work for you and you pay them for the support.

Until the next installment of DG, when Dr. D provides insight and guidance into complying with Annex III (EC Declaration 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. Retrieved September 12, 2011, from http://eur-lex.europa.eu

 

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Dr. Christopher Joseph Devine, President, Devine Guidance International