Similar to Article 5 of 93/42/EEC (the MDD), Article 5 (Reference to Standards) of the IVDD (98/79/EC), establishes the link and highly recommended need to comply with the harmonized standards; and the presumption of compliance with essential requirements. The primary difference being the IVDD strongly recommends that manufacturers comply with Common Technical Specifications (CTSs) for devices (reagents, reagent products, related calibrators, and control materials) specifically listed under List A; and List B (as applicable) of Annex II. Basically, CTSs reflect state-of-the-art performance-evaluation requirements employed for IVD medical device evaluations. Similar to harmonized standards compliance is not mandatory; however, compliance is strongly recommended.
Dr. D does not claim to be a haruspex (look-it-up); however, failing to employ harmonized standards and CTSs, whenever possible, in support of establishing compliance with essential requirements usually ends badly for IVD medical device manufacturers. Yes, the doctor clearly understands that harmonized standards and CTSs are only recommended. However, Dr. D’s position on recommended, has always been a “depends;” and I am not talking about the adult diaper type.
Similar to the MDD, the IVDD has a compiled list of harmonized standards to support conformance with essential requirements. For example, even though standards listed as harmonized are recommended, all attempts at having a quality system not premised on ISO 13485:2003 or device package labeling not in compliance with EN 980:2008 will probably result in device applications being delayed or flat-out reject by the notified bodies. Why – because some standards, although recommended, are just far too important to ignore; and trust Dr. D when I say, “your notified bodies will clearly articulate their positions on compliance when specific harmonized standards and CTS’s are not used”. For example, ISO 13485 is quickly becoming the quality management system standard adopted by regulatory bodies around the globe, e.g., Health Canada and CMDCAS. That being said, it is a safe bet regulatory bodies are looking for compliance with ISO 13485.
The IVDD – 98/79/EC
Article 5 – Reference to Standards
- Member States shall presume compliance with the essential requirements referred to in Article 3 in respect of devices which are in conformity with the relevant national standards transposing the harmonized standards the reference numbers of which have been published in the Official Journal of the European Communities; Member States shall publish the reference numbers of such national standards.
- If a Member State or the Commission considers that the harmonized standards do not entirely meet the essential requirements referred to in Article 3, the measures to be taken by the Member States with regard to these standards and the publication referred to in paragraph 1 of this Article shall be adopted by the procedure defined in Article 6(2).
- Member States shall presume compliance with the essential requirements referred to in Article 3 in respect of devices designed and manufactured in conformity with common technical specifications drawn up for the devices in List A of Annex II and, where necessary, the devices in List B of Annex II. These specifications shall establish appropriate performance evaluation and re-evaluation criteria, batch release criteria, reference methods and reference materials.
The common technical specifications shall be adopted in accordance with the procedure mentioned in Article 7(2) and be published in the Official Journal of the European Communities.
Manufacturers shall as a general rule be required to comply with the common technical specifications; if for duly justified reasons manufacturers do not comply with those specifications they must adopt solutions of a level at least equivalent thereto.
Where, in this Directive, reference is made to harmonized standards, this is also meant to refer to the common technical specifications.
What IVD device manufacturers need to know
As stated in the opening paragraph, the use of harmonized standards to support compliance with meeting essential requirements is strongly recommended in the EU. The Competent Authorities, representing each Member State, are quite fond of the harmonized standards. In fact, presumption of compliance with essential requirements is assumed, when harmonized standards are employed by device manufacturers. However, there is more. Sounds like a commercial, right?
If a Member State or the Commission deems a particular standard does not result in a device meeting its essential requirements, Article 6 of the IVDD can be invoked, essentially forcing a decision to review and/or revise a standard. Additionally, each Member State retains the legal right to modify and enforce standards they deem appropriate to support meeting essential requirements for devices entering into their Member State. To complicate matters even more, the IVDD introduces the term “common technical specifications.” Previously, CTSs were covered under Decision 2002/364/EC; however, as December 1, 2010, IVD medical devices were required to comply with 2009/108/EC, which amended Decision 2002/364/EC.
So what in the heck does that mean doctor D? Essentially, IVD medical device manufacturers must employ CTSs or provide written rationale when an alternate testing or evaluation modality is employed. Yes, Dr. D knows that the employment of standards in support of meeting essential requirements under the IVDD can be confusing. But wait, it gets better. Before settling on which harmonized standards or CTSs to use, the devices reflected on List A, under Annex II must be reviewed and understood. The use of the List will drive the decision on which CTSs the manufacturers of IVD medical devices will need to consider.
What IVD device manufacturers need to do
The doctor really hates to belabor a point because I always end up sounding like that proverbial “broken record.” However, if you want to make your lives as regulatory and quality professionals a little easier, employ the harmonized standards and CTSs whenever possible. Remember, the notified bodies that each of your organizations pay so dearly for the review of device applications and supporting technical documentation, relate to these standards. In fact, employing these standards will definitely improve the chance of receiving device application approvals quickly versus having to explain why a standard or CTS was not used. If an organization decides that a harmonized standard or CTS was relevant but decides to use some other recognized standard such as ISTA- 2A or an AAMI standard, written rationale is still required; documenting the decision to consider but not employ a standard. Yes, this sounds like a whole bunch of additional work, but the notified bodies demand this type of analysis to strengthen submissions.
As for CTSs, there really is not much wiggle-room. What you see is what you get, so be prepared to comply versus attempting to justify the use of alternative standards. Since IVD medical device manufacturers do pay for the service of their notified, bodies, do not be afraid to ask for help when it comes to understand the interpretation of a CTS. Competent notified bodies such as BSI and TUV-R (and no Dr. D is not a paid spokesperson for these organizations) are positioned to help their clients. All you have to do is ask, providing your organization continues to write the checks. Dr. D is just kidding, the doctor has worked with each of these organizations and they are always available and willing to answer questions, no charge.
Article 5 of the IVDD is all about the presumption of IVD medical devices complying with their essential requirements. The only sure-fire way to ensure compliance is achieved is through the application of harmonized standards and common technical specifications. In closing, yes Dr. D understands harmonized standards CTSs are strongly recommended; however, quality and regulatory professionals can make their lives easier by simply employing these standards.
Until the next installment of DG, when Dr. D provides insight and guidance into complying with Article 6 (Committee on Standards and Technical Regulations) of the In Vitro Diagnostic Medical Device Directive, a.k.a., IVDD – cheers from Dr. D and best wishes for continued professional success.
- AAMI. (2011, February). Association for the Advancement of Medical Instrumentation. Retrieved February 7, 2011, from http://www.aami.org/
- 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 Parliamentand of the Council of 27 October 1998 on in vitro diagnostic medical devices. Retrieved September 12, 2011, from http://eur-lex.europa.eu
- ISO 13485:2003. (2004, February). Medical devices – quality management systems – requirements for regulatory purposes (ISO 13485:2003).
- ISTA. (2011, February). International Safe Transit Association. Retrieved February 7, 2011, from http://www.ista.org/
- New Common Technical Specifications. (2009). UL European Notified Body. Retrieve November 8, 2011, from http://www.medicaldevices.org/node/212
- 2002/364/EC. (2002, May). Commission decision on 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices. Retrieved November 8, 2011, from http://eur-lex.europa.eu
- 2009/108/EC. (2009, October). Commission Decision of 3 February 2009 amending Decision 2002/364/EC on common technical specifications for in vitro-medical devices. Retrieved November 8, 2011, from http://eur-lex.europa.eu.