Are Harmonised Standards facing irrelevance?
There’s been considerable disquiet over the lack of availability of harmonised standards to support the new European Medical Device Regulations (MDR). And rightly so. But harmonisation is already in disarray and it’s getting worse, and risks becoming irrelevant to State of the Art regulation.
The neglect started some years ago: for arcane and apparently bureaucratic reasons, the European Commission hasn’t harmonised a single new medical device standard since 2017. In consequence, more and more European harmonised medical device standards are out of date compared to the current ISO revision.
And the work plan for the MDR risks publication of key standards which are already out of date on the day they are harmonised to the regulations
The Harmonisation Process
The process for harmonisation begins with the Commission issuing mandates to the European Standards bodies (CEN and CENELEC – which are European Counterparts to ISO and IEC) to develop standards for harmonization. Now, most of those standards already exist as ISO documents, so the mandate is actually mostly about preparation of the European (EN) version.
In almost all cases EN standards are technically identical to the existing ISO or IEC document but contain additional “Z-Annexes” which provide a table of cross references detailing specific clauses of the standard provide deemed compliance with a corresponding European Essential Requirement in the Directive. This is how harmonisation is meant to work. Compliance with an appropriate standard provides unambiguous evidence of regulatory compliance. It provides clarity for all parties as to technical expectations around safety and performance.
Once the CEN standard is finalised it is referred for review and then for formal harmonization by publication of a notice in the European Journal, such as this one.
All this seems perfectly logical and should be straightforward. But unfortunately, not so.
The review process is outsourced to an external contractor (currently Ernst and Young) who in turn use external technical consultants who actually review the documents. There are only three consultants covering the Medical Devices domain – so they have their hands full.
The consultants are working to a set of rules as to what’s acceptable. And they are very specific and contain all sorts of traps. Things like not allowing documents where the Annex Z includes a table of all Essential Requirements with only those applicable filled in, (the table should only include reference to applicable requirements), the standard having undated Normative references, stating that compliance requires reference to the whole standard (it must be done by specific reference to individual clauses containing technical specifications only) and not formally referencing the Commission mandate in the document. Any failures and the whole thing has to go back to the Technical Committee for revision.
This very particular process seems to have developed a serious backlog. Very few standards are making it through, and the entire process seems to have ground to a halt back in 2017.
The end result is that an increasing number of harmonised standards are out of date. And that includes some very important documents such as ISO 10993-1 – where Europe accepts the 2009 version as harmonised, whereas the current ISO was published in 2018.:
MDR to follow suit?
And it’s not going to improve under the MDR. In June 2019, the European Commission issued the Draft standardisation request as regards medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746. (PDF download)
This request identified the first batch of standards for consideration for harmonisation to the MDR and IVDR. There are a large number of standards in the mandate, some 57 revisions and 6 totally new standards for the MDR and 30 revisions and 4 new for the IVDR. There’s overlap so a total of 79 separate documents are in the work program.
Priorities are being given to a handful of key standards, specifically those on Quality Systems (ISO 13485), Risk management (ISO 14971), biocompatibility (ISO 10993-1), clinical trials (ISO 14155) and labelling (ISO 15523), including labelling for devices containing phthalates (ISO 15986).
The challenge is that of these six top-priority standards, four are under active review, with three of those about to be published. Yet the mandate specifically refers to current versions and the danger is, by the time they are harmonised, ISO will already have published later versions and Europe will be starting off the MDR with obsolete harmonised standards.
|Standard referenced by Commission||Status|
|EN ISO 13485:201||Under review for possible revision|
|EN ISO 14971:2012||2019 version in publication|
|EN ISO 14155:2011||Under FDIS vote for publication in 2019|
|EN ISO 15223:1:2016||Under active revision|
Status of High Priority Standards for MDR/IVDR
Now there is an out – deep within the Commission’s reference, there is an option for the standards bodies to suggest back to the Commission that a later version may be more appropriate. Then the Commission will have to review that proposal, and in due course issue an amended mandate, and then the documents will need to be reviewed again.
Hardly lean and efficient.
State of the Art?
There does, however, appear to be a pragmatic solution. Given the disarray, Notified Bodies are simply advising their clients to ignore the harmonisation list and to go straight to the current ISO version of standards. The reason: both the Directives and the MDR/IVDR regulations require devices to meet “State of the Art” and the current standard is considered to represent that. In fact for some key standards Notified Bodies seem to require that manufacturers use the latest version.
Now this seems to be fine in principle, but when a standard is controversial, regulators may not always accept a new version (remember the long dragged out process for moving on to the 3rd edition of IEC 60601-1? The potential for future controversy seems obvious.
Whatever happens, the real risk is the whole European harmonisation process is in danger of becoming irrelevant.
Which is a shame, because regulators elsewhere are becoming more consistent, and certainly more current in use of standards. US FDA has an extensive list of recognised standards. Even China is updating its national standards in a concerted effort to expunge out of date documents.
And other regulators (especially US FDA) have extensive device specific guidances which stand alongside standards.
So what are the key things a manufacturer should do?
- Be very careful when consulting the current Directives harmonised standards list on the Europa website. For every standard you expect to use, check carefully if there is a later version published by ISO or IEC, and consider using that.
- Don’t assume that anything on the current MDD/IVDR/AIMD lists of harmonised standards will carry over to the MDR/IVDR.
- If there is a discrepancy, talk to your notified body about it – and check that they are comfortable with you going to the later version (or, if you have test data against the harmonised version, check that they will accept it.
- Keep an eye on the ISO website, so you can see what changes are coming, and…
- …talk to your national standards body about what is happening. There will be local experts who are involved in the development of new ISO documents and they should be able to tell you what’s planned and when new standards are likely to be published.
If you have questions about how to navigate the use of standards and managing test programs, please reach out. We have a staff of consultants with extensive expertise. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ +61 2 9906 2984 (Sydney)