The door to Europe is closed – so where else should I look?

02 December 2019 |

Door closed

Early in 2019, the European commission was promising that by end of year MDR implementation would be well underway. There would be substantial numbers of Notified Bodies designated to perform assessments against both the MDR and the IVDR. Development of the European database EUDAMED, on which so much of the MDR infrastructure depends, was coming along nicely. All would be rosy in the Euro garden. Nothing to worry about, don’t panic, it will all be alright on the night.

As the year draws to a close we have only a handful of Notified Bodies designated. The Commission has just announced a two year delay in implementation of EUDAMED. European UDI is being implemented (but it’s different to US UDI). And all the Notified Bodies (designated or not) are completely overloaded, with waiting times to commence assessments for new customers exceeding a year and fees going up to eye watering levels. In fact, many of the larger Notified Bodies have simply closed their books, and are not accepting new customers at all.

Think about that for a moment. Imagine a start-up manufacturer with a new ground breaking technology which has potential to make a big difference to the health of European patients. They are unlikely to have an existing relationship with a Notified Body. So for them, there’s no way to enter the market for more than a year (an eternity for a start-up).

Put bluntly, while the rest of the world implements priority regulatory pathways for new technologies, Europe is closed for innovation.

We are hearing more and more stories of US firms who have an existing CE mark against MDD or AIMD, but who are finding that their current Notified Body is struggling to gain designation, or has announced withdrawal from the field. Some of these firms are simply abandoning their CE and withdrawing from Europe until it all settles down.

So what to do?

At last month’s annual meeting of the Asian Harmonization Working party, held in Oman, I participated in a panel discussion on the state of harmonization. The new buzzword, especially in emerging markets, is Reliance. In essence, the practice of regulators utilizing reviews conducted by other agencies as input to their own regulatory decision-making.

Now regulators the world over have been doing this for years. Reliance has been encouraged by the GHTF and other harmonization groups like AHWP. GHTF, in particular, established a global consensus regulatory framework which borrowed heavily from the European approach, and which formed the basis of regulatory reform in many jurisdictions around the world. So it’s not surprising that the most common approval relied upon by smaller agencies is the CE mark. Not least here in Australia, where more than 90% of Australian device registrations requiring TGA review are approved based on prior CE marking.

Now that CE marks are destined to become rarer, at least in the short term, this reliance on prior European review is under threat. Those agencies used to leveraging CE will need to either do more reviews themselves (and there just isn’t the capacity to do more in many smaller agencies). Or they must look elsewhere for international evidence.

That brings its own challenges. Few other larger agencies (mainly the IMDRF members) have systems closely aligned with the European/GHTF model. Really only Canada comes close. So finding an assessment based on similar processes and criteria is difficult.

But again in Australia, TGA – which has been inherently conservative in accepting international evidence – has, nonetheless, managed to find a way. TGA now uses reliance on the other founder members of the GHTF (Canada, Japan and USA) to expedite regulatory approvals in Australia.

TGA will accept either CE or a regulatory approval in one of these large jurisdictions, providing the manufacturer also has combined with an MDSAP certification including Australia within scope or a Japanese Quality Certification.

Australian reliance on international assessments for Australian registrations

There are other caveats, classifications must also align with those of Australia. That’s easy for devices approved in Canada (almost identical requirements to Australia) and mostly for Japan, where the classification systems are broadly aligned. But it’s not so easy for devices relying on US FDA assessments. Many devices at Class III in Australia are Class II in the US, and a 510(k) assessment won’t be enough to satisfy TGA for a Class III approval.

Similar approaches are taken with a number of jurisdictions across the Asia Pacific and further afield. Singapore, Indonesia and Taiwan are just three examples of agencies which rely on prior international assessments for abridgement of local reviews, often with much faster processing times.

So the lesson is, while it’s uncertain and difficult in Europe, there are many other opportunities in other parts of the world, and these markets can be accessed quickly based on international approvals especially from the US FDA and other GHTF founder members.

Time to look across the Pacific?

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)


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