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.
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 thefollowing 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.
- Select the appropriate category (List A versus List B).
- Define and establish compliance with essential requirements.
- Establish an effective post-market surveillance system.
- Have the Chief Jailable Officer (CJO) prepare and sign the Declaration of Conformity (DoC) – Extremely Important.
- Send the device application to your notified body.
- Once device approval is received, affix your notified body’s CE mark of registration to the product packaging.
- Commence with shipping product into the European Union (EU).
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).
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.
- 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 for complying with the European medical device directive – MDD. Charleston, SC: Amazon.
- Devine, C. (2012). Devine Guidance series on complying with the IVDD. 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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