The European Medical Device and Active Implantable Medical Device Directives have for more than 20 years provided the “best practice” regulatory model which has been adapted into so many other markets around the world. But now Europe has changed and introduced the new Medical Device Regulations (MDR). How will other markets deal with the regulatory disconnect between the new European Model and the now outdated copies around the world? Is this new global disharmony a threat – or can others follow Europe’s lead and take the opportunity to deliver a more harmonised global regulation?
Although Global Harmonisation Task Force (GHTF) is no longer active, the GHTF regulatory model has been adopted in many markets. It was always a European model – the device classifications, Essential Principles and Conformity Assessment procedures are essentially close derivations of the European Directives.
The GHTF provided an international consensus which enabled rapid take up of the new regulatory model by others. First Canada in 1998, then Australia in 2002 introduced new regulatory systems closely modelled on the GHTF/European Directives. Since then elements of the European model – especially risk based classifications and Essential Requirements and reliance on international technical standards to establish compliance, have found their ways into regulations in jurisdictions as diverse as Japan, China, Singapore, Malaysia and Saudi Arabia.
This broad-based consensus of approach then allowed many jurisdictions to leverage the European reviews. Since the requirements and assessment processes were so similar, a prior CE marking became a kind of passport to abridged reviews in many other jurisdictions.
Not quite in tune
Having said all of this, as the various international agencies adopted the European model, the temptation to introduce local variations was just too hard to resist.
The regulations here in Australia provide a good example. For some arcane reason, Australians must have slightly larger central circulatory systems than Europeans! the Australian definition includes the common iliac arteries, which are not included in the MDD definition, causing headaches for manufacturers of stenting systems where the components contacting the common iliac are Class IIb in Europe but Class III in Australia.
Whether the European or Australian definition is the right one is a separate argument. Such local differences create inefficiencies for manufacturer and regulator alike.
But now Europe has changed. In response to global concerns about adequacy of regulation of higher risk implantable products, the new European regulations have tightened clinical evidence requirements and adjusted classifications.
But at the same time the European upgrade introduces even greater disconnects with the various international variations of the GHTF model.
At a high level – the regulatory risks are small. European standards have tightened, so CE mark should be recognised as an even better assurance of safety and abridgement pathways could in theory continue as before.
But as classifications and requirements move further apart the administrative inefficiencies will compound.
A better model
There’s no doubt the new MDR introduces greater rigour and more stringent requirements. But there’s much new value in the MDR. The drafters of the MDR have taken the opportunity to provide so much more detail in the regulations and to clarify a number of areas of regulation which have been ambiguously applied.
Software – made simple
Perhaps the best example of the introduction of much needed updates is in the treatment of Software. The new European classification rules elegantly integrate the device classification rules with the long-established software classification rules embodied in IEC 62304 (and also in the US FDA guidance where the classifications are called “Levels of Concern)”. The Safety and Performance Requirements include at a high level the now well established IEC 62304 software life cycle controls and validation models. The regulation of software in the new MDR provides a simple clear and integrated approach which would be a worthwhile upgrade to all GHTF based regulatory systems.
Bringing more science into regulation
In general, the changes embodied in the new Safety and Performance Requirements reflect developments in scientific knowledge and consensus since the original introduction of the European Directives in the 1990s.
The new regulations include a much-expanded set of General Safety and Performance Requirements which replace the old Essential Requirements. There’s so much detail here which in some cases is substantially more prescriptive. For example, requirements for biocompatibility quite explicitly expect much closer review of materials characteristics and processing; and even more explicitly set out requirements for justification of the presence of endocrine disruptors (e.g. some phthalates).
The MDR also recognises technological change. Custom devices (previously things like dental fixtures and orthoses and spectacle lenses), have been exempted from premarket review. But as 3D printing and other advanced manufacturing techniques are adopted, custom devices are now just as likely to be not high risk implants and the new MDR brings commercial manufacturer of such devices within the same conformity assessment review as for all implants.
The challenge for other jurisdictions seeking to re-align with Europe is that there are a number of cross references to other European Regulations for which there may be no direct local equivalent. That will again provide fertile ground for local variations.
A better harmonization?
Those regulators around the world using GHTF based regulatory systems will need to react. There will be two separate drivers:
- The increased mismatches in classification and requirements will create administrative overloads as the CE evidence will no longer exactly match the local requirements in the various international GHTF jurisdictions.
- There is likely to be local pressure from clinicians and patients for upgrade of regulations to match the tightened requirements in Europe.
Within all of this lies an opportunity to re-align the regulatory systems of Australia, Canada and other GHTF model regulators to match as closely as possible that of Europe.
Review of other GHTF model regulatory systems will undoubtedly receive strong support from clinicians and users – after all it represents an upgrade to the new “tighter” European rule set. There will be a political tailwind to such reforms.
For manufacturers, this may seem to be painful in the short term – after all it involves change and an increase in regulation in markets outside of Europe. But Europe is the world’s second largest market and in this global industry most manufacturers will seek a CE mark. So other markets following suit creates no additional long term load on manufacturers. Rather it reduces all those local variations which create so much inefficiency.
So – as international regulators contemplate updates to follow the European changes, the key question should always be – is there a demonstrable local difference in circumstances which generate new risks to justify a different requirement to the European one?
The question is can industry and regulators alike seize the opportunity – to weed out all those local variations and create a more globally harmonised medical device regulation?
- European Medical Device Regulation (PDF / HTML Web page)
- European IVD Regulation (PDF / HTML Web page)
- Official journal for links to multiple language versions
- Medical Device General Safety and Performance Requirements (MDR Annex I)
- Medical Device Classification Rules (MDR Annex VIII)
Click here to download
Blog – Summary of changes
Seeking to understand the new MDR and the implications for European market access? Need to use your CE to leverage other markets? We are experienced in European compliance – from development of Technical Files, to preparation for CE audit, to local variations in other markets. Contact us for a no obligation discussion on how we can support your compliance and market access. Email email@example.com or call +61 2 9906 2984.