At the Irish Medtech Global Access conference in Galway this week, a common theme emerged: planned transitional arrangements schedules for ISO 13485:2016, the European Medical Device and IVD regulations and the Medical Device Single Audit Program (MDSAP) will combine to create a Perfect Storm which will challenge the resources of regulatory agencies, assessment bodies and manufacturers alike. You may think things are getting busy now, but in reality we are in the calm before the storm.
Three substantial regulatory reforms are entering transition periods which play out over the next 3-5 years:
- ISO 13485:2016 transition will take place between 1 March 2016 to 1 March 2019. Issue of new certificates to ISO 13485:2003 is permitted until March 2017, but after that their issue will be strongly discouraged (read “almost impossible to get”) and after March 2019 all new certificates must be to the 2016 version of the standard.
- MDSAP will become the Mandatory replacement for the CMDCAS certification to support Canadian device approvals. This changeover occurs on 1 January 2019 – 3 months before the end of the ISO 13485 transition. By then it’s expected that Europe will also have joined the MDSAP program.
- European Device and IVD regulations are expected to be approved in 1st quarter of 2017 – kicking off a 3 year transition for medical Devices ending in early 2020 (the IVD regulation has a longer, 5 year transition). However, given that it’s expected that Notified Bodies will not become accredited to the new regulations until at least mid 2018, it won’t actually be possible to start issuing certificates to the new regulations unitl 2018-19. The European Union is already considering granting grace periods to manufacturers whose current certificates expire the middle of the transition, in case the Notified Bodies are not yet qualified to certify to the new regulations
In addition to all of this, the step up in regulatory expectations in Europe are creating much more work for assessors and manufacturers alike in meeting the new expectations. The higher standards for qualiification of Notified Bodies is leading to a shake out and reduction in number of Notified Bodies, resulting in those remaining having to take on additional clients. We are already seeing a marked increase in processing times, with some Notified Bodies struggling to accommodate the extra workload.
So what does this all mean?
It’s going to be unbelievably, frantically busy in 2018-19. By then, European Notified Bodies especially will be trying to deal with CE and ISO 13485 transitions at the same time while also meeting the higher assessment standards under the new regulations. Their international (especially North American) divisions are going to be in the thick of MDSAP audits as well as ISO 13485 transitions.
- Manufacturers: know when this will affect you. Manufacturers need to be thinking now, right now, about how they will manage their transitions. In particular – manufacturers should know when their current CE and ISO 13485 certificates expire and require full re-certification audits. This is critical. You need to understand when you will need to be ready. It’s very important to understand that Notified Bodies are highly unlikely to be able or willing to be all that flexible around timing.
- Plan and prepare – thoroughly Yes we know that all things regulatory and quality require planning, but this time we really mean it. Getting through this will require all of the processes to be thought through well in advance, timeleies and resource requirements to be understood and the making of very solid preparations.
- Don’t try to be too clever. In particular, anyone thinking of using the tactic holding back and then sneaking in late by converting a surveillance audit to a full recertification audit towards the end of the transition – think again: that request is likely to be denied.
- Don’t miss the boat for Canada If you intend to commence or continue marketing in Canada, you should be thinking now about enrolling in the MDSAP program. The take up so far has been around 100 compaies – bt that is growing very rapidly indeed. And there are a lot fewer MDSAP auditors at the moment than there are Notified Bodies. Get in quick – or you may find yourself at the end of a very long queue.
- Are you becoming higher risk? And if the re certifications aren’t challenging enough. For CE marking: it’s important to take a long hard look at the changes in the risk based classifications in the new European regulations. A whole range of devices have been up-classified, meaning additional requirements for assessment and for evidence, especially more rigorous approaches to clinical evidence for devices moving up into Class IIb or III.
And the good news? Well, there isn’t much. This is going to be hard and exhausting for all concerned.
Perhaps the one bright light here will turn out to be the MDSAP program. Once up and running it promises to substantially trim the assessment burden for regulators and manufacturers. For sure, MDSAP audits will be longer and more complex, and that will be especially hard for smaller companies. But they will replace the current need for multiple audits and assessments by many authorities and jurisdictions. MDSAP is already paying dividends to those trying to market in Brazil, where the notorious waiting times for ANVISA audit are adding years to registration timelines, where those with MDSAP certification avoid the wait. MDSAP will soon be the only way to get into
Further afield- the CE mark is a de facto passport to many other markets. Australia’s TGA registers the bulk of devices on the basis of CE certification. CE is used to enable access to abridged review processes in most emerging markets of South East Asia, the middle east and elsewhere. So all of this has ramifications far beyond Europe.
Finally, a real shout out to The Irish Medtech Association for a first class conference. Two packed days of highly knowledgeable speakers and some really in depth exploratons of current topics and practice. It’s on every two years in Galway. The next one is scheduled for 2018. You should be there, meanwhile.. .. batten down the hatches…
Need help in preparation for the new Europan regulations or transiiton to ISO 13485:2016. Considering MDSAP? Trying to formulate an international strategy to cope with all these gloal changes? Call us for a confidential chat as to how we can help you get the strategy right and support you through the changes. Contact us: Email email@example.com