Since the inception of the “New Approach” back in 1985, the key concepts of the use of Harmonized Standards and Presumption of Conformity have provided medical device vendors with a valuable tool in meeting legislative and regulatory requirements in the EU. But over the last few years, the addition of the Z Annexes to many of these documents have certainly caused many of Document Center’s clients headaches! So I thought that a little review of the New Approach, Harmonized Standards and Presumption of Conformity might be in order.
The New Approach was developed to assist Europe develop a common market. It makes use of standardization as a tool for creating common requirements within the group of nations that make up the EU. It relies on legislation to mandate performance levels and a standardization scheme to provide a path to meeting those performance levels. This use of a body of standards (your harmonized list) to fulfill legislative mandates is know as the presumption of conformance.
Of course, use of the harmonized standards is not the only path to conformance. A company can choose another solution if they prefer. However, they will need to “make their case” for conformance in a way that is not necessary had they decided to meet the requirements of specific harmonized standards instead.
Why have standards on the harmonized list for medical devices run into so many issues with the intended “presumption of conformity?” The Medical Device Directive, The Active Implantable Medical Device Directive and the In Vitro Diagnostic Medical Device Directive all have articles that in some cases are not strictly met by clauses in the corresponding standards adopted from ISO and IEC. These gaps may be spotted by a review of the Annex Z’s in the documents in question.
These Annexes match legislative mandates to specific clauses within a particular standard. Where there are discrepancies, this is noted. Additionally, certain standards may not address all the requirements of the legislation, but only particular articles.
During the last couple of years, as certification has raised flags regarding the correlation between the legislative requirements and the reality of the harmonized standards, these Annex Z’s have been undergoing changes. And since the changes reflex a degree of compliance to the legislation that was not considered practicable when the standards were first developed, you can see that there’s going to be an issue raised for many medical device manufacturers.
Of course, standards do represent “state-of-the-art” in many cases. However, with increasing concerns about risk assessment, etc., the use of the medical device harmonized standards no longer confer the degree of conformance as they once did.
When will this issue crop up for you? You will have to address it when a new edition of one of the standards on the harmonized list is updated. The “date of cessation of presumption of conformity” will be your target date for compliance. That is, you will need to have moved from the old edition to the new by that date on the harmonized list publication. Any device already placed on the market in Europe by that date will not be affected. However, any device sold after that date will need to meet the new update.
What is required to make the move from one edition to another? You will need to confirm that your product’s “justifications” for conformity are valid using the new standard’s requirements by that expiration date. In order to determine the changes you’ll need to make to your product (if any), a gap analysis is required. You’ll review the two editions and see if the changes in the revised document impact your product and it’s “technical file.” Should it not impact your product, nothing further is required. If it does, retesting will be in order.
It is unfortunate that some of the basic tenets of the New Approach have run into difficulties where medical devices are concerned. Certainly, it appears that some of the trouble has occurred because of the preference of the European system to adopt standards developed at the International level when possible. Since Europe makes up 20% of the membership of the International standards organizations, it is a great economic benefit to have standards aligned at both the international and European regional levels. However, in the case of some of these medical device standards, the degree of risk mitigation is not stringent enough at the international level to meet the European legislative requirements.
Of course, these changes are rippling through the standards community even as we speak. Will the net result be a change to the legislation or changes to the standardization? Only time will tell…
If you need help with your documentation for compliance, turn to Document Center Inc. We’ve helped thousands of companies just like yours. Reach us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). Or head to our website at www.document-center.com. We’re your Standards Experts!
