Here at PRISYM ID, we have recently conducted a survey of international medical device manufacturers, to ascertain their understanding of EU MDR, and the implications of the new regulation on label lifecycle management.
The majority of the one hundred respondents who took part in the survey are from organizations that produce medical devices within Europe; yet only 17% of respondents state they are fully aware of the changes to to the previous European Regulation Medical Device Directive. 31% - 39% of companies are somewhat/reasonably aware of the new regulation, but a staggering 14% are not aware of the new regulations at all.
Yet, with 72% of respondents believing that EU MDR compliance will have a high/medium impact on their business, it is clear that those who are currently not fully aware of the upcoming changes, need to start their due diligence in order to meet the 2020 provisional completion date.
Having said that, amongst the overall survey respondent base there is a high level of confidence that a solution will be in place to meet the deadlines. 44% are ‘confident’ and 39% ‘probable’ that they will have a solution in place by 2020. Half of the organizations surveyed have already started to address the EU MDR and understand the planning process for implementation. However, 12% have not yet started to think about it and are waiting for the legislation to be approved before making any arrangements.
If you want to be ahead of the game, you need to start now. The bottom line is, if your license is delayed you will not be able to supply your devices. The later you start, the higher this risk becomes.
One of the new, specific aspects of the regulation is the requirement of Unique Device Identifiers (UDI), allowing the ability to trace a device from its manufacturer through the supply chain to the final end user. UDI is required to be added to the product packaging and labeling. 70% of the organizations that took part in the survey have already implemented the USA’s FDA Unique Device Identification (UDI) Regulations, although 9% are unsure. As our previous UDI survey highlighted, many organizations underestimated the impact of the regulation on their business processes, required skillsets, and specific operational requirements around label lifecycle management. The EU MDR survey shows that over a third of replies recognize that additional skills are going to be required. Only in understanding of the regulations and their implications do we achieve just over half believing that they have the resources available internally.
The survey reveals that 39% of the respondents consider Regulatory Affairs the area of the business that EU MDR will have the most impact upon. The remaining 61% opinions are split between Packaging, Operations, Distributions, Commercials and other. When implementing the UDI, the regulation was seen as a department specific project for labeling and regulatory teams. As you embark on your EU MDR implementation consider what departments need to be involved in the solution.
The reality is that in today’s increasingly competitive and regulated global marketplace, organizations are left increasingly vulnerable to mislabeling, voluntary recall, non-compliance and non-adherence.
Changing regulations, such as evolving UDI, EU MDR or the EU clinical trial regulations, need to be incorporated into the label and artwork processes appropriately, and in time for when the regulation takes effect. And our PRISYM 360 solution may be the right one for you.