Article 3 (Essential requirements) of the IVDD (98/79/EC) is essentially (no pun intended) identical to Article 3 of the MDD (93/42/EEC) minus the MDD’s paragraph addressing hazards and machinery. Regardless of the Directive (MDD or IVDD), Article 3 has always been one of Dr. D’s favorites because of the utter simplicity of the requirement. In fact, it does not get much easier than a one-sentence Article. There is no Euro-legalese, associated regulatory jargon or infinite do-loops, just a simple statement of compliance. The doctor often sees the failure to meet essential requirements as the hamartia (look-it-up) that often prevents IVD device manufacturers from reaching the European market.
The IVDD – 98/79/EC
Article 3 – Essential Requirements
Devices must meet the essential requirements set out in Annex I which apply to them, taking account of the intended purpose of the devices concerned.
What IVD device manufacturers need to know
IVD medical device manufacturers must ensure their devices meet established essential requirements. Sounds like a pretty simple concept, right? Unfortunately, meeting essential requirements continues to be a challenge for device manufacturers. Annex I of the IVDD delineates the ground rules for establishing essential requirements. In fact, Annex I contains sufficient granularity to lead the doctor to ask the question, “How can device manufacturers not understand the salient requirements?” But hey, maybe it is the over-abundance of granularity and the level of detail that is the actual root of the problem.
While Dr. D will review and provide guidance for Annex I later in this series, it is impossible to separate Annex I and Article 3 when discussing the virtues and finer points of meeting essential requirements. That being said, Annex I prescribes the salient requirements for:
A. General Requirements; and
B. Design and Manufacturing Requirements.
Meet the prescribed requirements depicted in Annex I and the manufacturers of IVD medical devices can affix the CE mark, containing the registration number of their notified body, onto their product, once all of the approvals have been obtained.
So what are the basic fundamentals associated with meeting essential requirements? According to Dr. D it all begins with the design and development of medical devices that are safe and effective, period. In fact, the Directive is extremely clear about IVD medical devices being designed, manufactured, and packaged in such a way to ensure the device functions in its intended use. Additionally, the expectation is that device manufacturers establish a fully-functional quality management system (QMS) to support compliance with all aspects of the IVDD. It is the job of the notified body to ensure the QMS is effective. For those readers not familiar with ISO 13485:2003, this standard is the blueprint for device manufacturers wishing to establish a QMS capable of meeting the rigorous regulatory environment needed to sell product into the EU. In fact, design control activities, including design verification and validation, are important activities identified in the text of ISO 13485.
Meeting essential requirements does not stop with the design as a robust design is only one brick in a device manufacturer’s quality and regulatory foundation. Once designed, device manufacturers must manufacturer, inspect and test IVD medical devices to support the claim of meeting essential requirements. As part of this effort, Dr. D always recommends employing Harmonized Standards to support meeting essential requirements. Yes, the doctor understands that harmonized standards are only recommended; however, Dr. D has also suffered through the pain of attempting to defend notified-body submissions not employing these standards. Trust the doctor when I say, “It is just not worth the pain and ultimate delay in application approval by not using harmonized standards, whenever practical.”
A key deliverable that IVD medical device manufacturers will need to provide is the Essential Requirements Checklist (ERC). This document will contain a compilation of all of the relevant standards (hopefully harmonized) employed to perform validation, verification, testing, inspection, manufacturing, etc. The notified body should be able to provide the device manufacturer with an ERC template.
Similar to the MDD, IVD medical device manufacturers will need to prepare technical documentation (technical file or design dossier) to support device applications. The classification of the device will determine the regulatory pathway and technical documentation requirements (reference Annex II List A and List B). Additionally, a signed Declaration of Conformity (DoC) remains a fundamental deliverable under the Directive. The Chief Jailable Officer (CJO) will be required to sign a DoC and submit the document to the notified body. Finally, when the device application and all of the associated documentation has been reviewed and approved by the notified body, then and only then can the CE mark be affixed.
One final thought, remember only one application can be made with one notified body at any given time. Simply stated, “Device manufacturers cannot have multiple applications for the same device with multiple notified bodies at the same time in the EU.” Before, I forget, one more final thought: “Please do not forget to keep and maintain records.” Why? Because the Competent Authorities, upon request, “typically when bad things happen,” will want to review an IVD medical device manufacturer’s records.
What IVD device manufacturers need to do
Let me begin by saying, Dr. D is not trying to be smart-alecky with my next comment, well maybe just a little. “IVD medical devices must conform to their established essential requirements (duh, duh-duh). Because every device is going to have its own requirements to meet, premised on classification and intended use, the doctor cannot provide the “on-shoe-fits-all” blueprint. Dr. D can only emphatically state, “It depends.” However, there are some concrete tangibles that device manufacturers will need to do in support of meeting the intent of Article 3.
- IVD medical device manufacturers can start by ensuring their devices meet established essential requirements (yes- broken record time but no surprises).
- Read and become intimate with Annex I of the IVDD. Having a thorough understanding of the requirements will result in hopefully a mistake-free application process, but hey that rarely happens.
- Ensure that your notified body has adequate experience in working under the IVDD umbrella, especially when it comes to understanding the device class and the employment of Lists A and B of Annex II.
- Whenever possible, always use harmonized standards.
- Make sure the CJO signs the DoC (gosh Dr. D loves his acronyms).
- Once approval is received, do not forget to affix the CE Mark.
The primary takeaway from this guidance is that IVD medical devices must meet established essential requirements. Annex I of the IVDD delineates the details for establishing essential requirements. However, it is the strong opinion of Dr. D that the path toward conforming to essential requirements begins with a robust design and development process that ultimately results in an IVD medical device that is safe and effective in its intended use.
Until the next installment of DG, when Dr. D provides insight and guidance into complying with Article 4 (Free Movement) 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 series on complying with the MDD. Published in The Medical Device Summit. http://medicaldevicesummit.com
- 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
- EN ISO 13485:2003. (2004, February). Medical devices – quality management systems – requirements for regulatory purposes (ISO 13485:2003).