Halfway there? Will the MDR/IVDR train arrive on time – and what about Brexit?
As the implementation journey for the EU MDR/IVDR passes the halfway point, we provide an update to the current state of play and the impact on our industry.
Many, if not all manufacturers are seeing delays and challenges getting their MDR certification programs underway. The sheer investment required to meet the new regulations is a substantial load. The major areas of pain include:
- Up classifications of a risk category for several products
- Significantly higher bar for clinical data and post-market surveillance
- Inability to successfully engage with a notified body (many are now reporting 9-12 month waiting lists)
- Lack of clarity and understanding of the new requirements
MDR/IVDR Transition Period
Although it’s expected that the implementation will proceed according to the scheduled dates, the European Commission (EC) is expecting to see some exemptions made available within the two regulations. These exemptions are likely to be for extensions of the validity of old certificates, exemptions for certain devices from the updated clinical investigation requirement, and the EC is expecting to continue to receive applications for further exceptions.
Notified bodies continue their journey to designation. A total of 34 have applied for redesignation and are currently undergoing review.
The following is a list of members of notified bodies association Team-NB seeking redesignation (see here for the original). There are a few more outside of Team-NB membership, but this list represents most of the significant players. It’s the best available snapshot of what the MDR/IVDR assessor population will look like.
|0473||Intertek AMTAC Certification Services||UK||*|
|0086||BSI Product Certification||UK||*||*|
|1912||DARE!! Medical Certifications||NL||*|
|0124||DEKRA Certification GmbH||D||*|
|0344||DEKRA Certification B.V.||NL||*||*|
|2460||DNV Nemko Presafe AS||NO||*|
|0483||mdc medical device certification||D||*||*|
|0044||TÜV Nord Cert.||D||*|
|0197||TÜV Rheinland LGA Products||D||*||*|
|0843||UL International Limited||UK||*||*|
Remember the total number of Notified Bodies under the three Directives exceeded 80. The reduction to 34 is not quite as bad as it appears, because most of the dropouts are the smaller Notified Bodies. All the big players remain. Nonetheless, there are fewer and some will be narrower in scope, so there will be a noticeable fall in capacity.
Things will be particularly tough for diagnostic IVD manufacturers. Given that the IVDR represents a substantial increase in regulation. Under the current IVDD, around 20% of IVDs are covered by the List A/B classification scheme and require review. Under the IVDR, more than 80% of IVDs will be in Class 2-4 and require assessment. A similar change in regulations happened in the much smaller market of Australia over a lengthy transition from 2010-17 and led to a substantial industry shakeout plus inevitable delayed reviews and considerable backlogs. In Europe in the face of this very substantial increase in regulatory burden, only 11 Notified Bodies are seeking IVDR designation – a cut of around half. This is unlikely to end well.
Perhaps the biggest concern is in high-risk devices, whereas few as three notified bodies may be designated as able to certify Class III devices, including active implantables. Given the substantial increase in clinical evidence requirements, this will be a major challenge.
The big question is will EUDAMED, the new pan-European consolidated regulatory database, will be ready on time.
Manufacturers will be expected to maintain all files and records to comply with the new EUDAMED reporting requirements as of the implementation date. Clinical data from trials will also be required to be entered EUDAMED along with a number of post-market data not previously required.
A recent report published by the EC claims that the development of the database is still on track. Expected completion of the specifications is Q4 this year. Auditing of the system starts in late 2019 and it must be completed by 2020. There is also an intention to have a helpdesk in place prior to the go live. https://ec.europa.eu/docsroom/documents/31902?locale=en
But this is a huge undertaking, covering registrations, labelling, product information, assessment and audit reports, and a raft of different periodic postmarket reports. Access is at multiple levels, with Competent Authorities, Notified Bodies, manufacturers, other economic operators like distributors and Authorised Representatives and the general public all having different levels of access, and everything done in the multiple languages of the 27 member states. There’s an enormous amount of sensitive information in EUDAMED. Forgive our scepticism, but it’s a herculean job and we expect further delays.
Understand the NEW requirements
Multiple products, specifically software as medical devices and dental products will also be up classified and there’s a risk that some will fall short of the new requirements.
Post-market surveillance is a key component that is changing with MDR, with a focus from reactive reporting/auditing to proactive surveillance and periodic reporting via EUDAMED, some of which will be in the public domain.
Changes in liability set a higher bar for Authorised representatives, who will now assume shared (joint and several) product liability. This will inevitably lead to a shakeout of many of the smaller players and an increase in costs of insurance and due diligence.
Amongst all of this, there’s the additional disruption of Brexit. Not only does that mean the UK competent authority MHRA, one of the key participants in the entire regulatory framework will be excluded, but five of the bigger Notified Bodies seeking redesignation (SGS, LRQA, BSi, Intertek AMTAC, UL International) are currently based in the UK and are likely to need a new home elsewhere in Europe. See here for our earlier review of the consequences of Brexit.
Certainly, in our recent travels, there have been numerous panel discussions, meetings and general comments around the points raised above. And as much as the EC attempt to ease these fears, the reservations continue to exist. Europe particularly will be challenging for some time.
So what to do?
- If you supply to Europe, then make sure you are in active communication with your Notified Body, understand what you need to do and prepare, prepare, prepare. If you’re not speaking to a Notified Body yet, then you have an emergency on your hands.
- Consider the opportunities opening up as the world looks for other ways. The Australian opening up of recognition of US, Canadian and Japanese evidence is a prime example. Do take a close look at MDSAP. It’s now getting real momentum and is not as hard as people will tell you. Take a look at our recent webinar on how MDSAP can open a world of opportunity.
Written by Grant Bennett and Luis Jimenez.
We offer deep support for manufacturers navigating European and other international regulatory processes. Whether it’s a strategy for MDR transition, 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. Reach out today and start a conversation. Contact us for a free, no obligation discussion. Email [email protected] or call us: 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)