I previously wrote an article for MedTech Intelligence where I explained what changes the New Medical Device Regulation was going to bring to the industry and how manufacturers could best prepare for the hurdles and challenges that would inevitably follow.
We are now one year into a three-year transition period towards the final implementation of the new European Union Medical Device Regulation (MDR); in May last year, the Official Journal of the European Union announced the start of the MDR implementation process, confirming 2020 as the year when it will enter officially into force. Let’s analyze the current situation: What has been achieved to date, and what is there left to do for manufacturers?
Unfortunately, the regulatory landscape is not as promising as it should be when it comes to MDR implementation; companies are struggling to meet the compliance deadline, and it’s getting hard to believe that all manufacturers will be MDR-compliant by the set deadline. The extended EC certificate validity period, coupled with the time it is taking to re-designate the various Notified Bodies (NBs), surely means that a timeline extension has to be inevitable. All that said, the European Commission (EC) has openly disclosed that they are not prepared to go down this route, presumably as it could lead to the industry taking its foot off the accelerator.
There has also been an on-going debate about NBs, which has been at the heart of the industry’s agenda for the last year; the much-discussed decrease in the number of NBs around Europe means they are being pushed to their full capacity, which raises concern about the effect this will have on meeting MDR compliance requirements. It has already been anticipated that with the new regulation coming into force there will be an increase in demand for the NBs services, which is compounded further by the growing pressure that the NBs are already facing from their Competent Authorities, particularly after a string of highly publicized safety breaches.
Despite the obvious concerns that this situation raises, NBs have commented that they are not yet responsible for any bottlenecks. Some of them in fact, agreed on saying that overall the industry has been progressing slowly towards the MDR transition, giving them time to deal with the high demand efficiently. Nonetheless, it’s important to bear in mind that even if the situation has not been hugely affected by the NB capacity, it can still potentially pose problems in the future.
However if NBs are not yet to blame, what is causing manufacturers to be slow on the uptake? One of the reasons could be the on-going battle with the ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP), both of which have shorter regulatory deadlines than MDR. Instead of focusing on one transition at a time it would be more convenient for manufacturers to phase in these transitions simultaneously.
A delay with complying with the new regulation can have a severe impact on the business, especially in light of the growing lack of available skilled in-house compliance professionals. When the time will come to source talent, manufacturers who have been slow in MDR uptake will have to deal with a slim and more expensive selection of resources; the whole life sciences industry is facing such an issue, with up to 80% of clinical research professionals working freelance and not in house.1
It is also important to not overlook the problem of Brexit – a delayed transition period would only add confusion to an already complicated scenario; the changes that the industry will have to face after Brexit are still an enigma and it’s important for manufacturers to not be taken by surprise and to be prepared to put in place any further action that might be required in the following years.
After one year into the transition process it is possible to say that there is still a lot to do. Despite potential hurdles, manufacturers should not rely on the possibility of an extension for transition and should try and act swiftly and efficiently to avoid further delay.
- Clinical Leader (November 6, 2016) Clinical Staff Shortage: “Growing Plague” For Pharma & CROs.