The medical device directives are currently being revised by the EU’s institutions in a process that began in 2008. This revision has the following objectives:
- To ensure a consistently high level of health and safety protection for EU citizens using these products
- To maintain the free and fair trade of the products throughout the EU
- To adapt legislation to the significant technological and scientific progress that has happened in this sector over the last 20 years
At the recent Med-Tech Summit in Brussels (14-16 June 2016), 350 key decision makers listened to how the industry is responding to these directives. We were particularly impressed with the presentation from Geistlich which we feel could be of value to other small-medium sized medical device companies.
Two years ago in 2014, the company began the compliance process; gathering clinical evidence, making sure that it had liability insurance and carrying out unannounced audits among other preparations.
The following year, the company drew up a detailed budget for its preparations, allocating €1.2 million alone for clinical evidence work, €200,000 for work on ‘approval via scrutiny’, and €100,000 for ‘high risk medical devices’.
By 2016, the company was ready to allocate specific days per year for certain tasks. Having someone in the ‘regulatory compliance (qualified person)’ role for example, would take 220 days per year, while clinical evidence was the most time-consuming, with 440 days. Dealing with the EUDAMED system, ‘post market clinical follow-up’ and high risk medical devices would all take more than 100 days per year.
A further step was then to carry out specific tasks in advance of UDI registration. These included a gap analysis with quality control, technical operations, clinical, marketing and sales departments; identifying time consuming issues, planning certification, planning and performing clinical trials of new and already certified devices; planning and performing post market clinical follow-up and ensuring that the notified body agrees with a clinical trial before starting it.
New quality system (QS), regulatory affairs (RA) and clinical personnel had to be recruited, while liability insurance had to be evaluated. There had to be a renewed focus on traceability, on preparing the education of economic operators and on the adaptation of economic operators’ contracts.
Crucially, the company had to plan for new packaging, ahead of device registration.
And finally, it had to plan for unique device identification in Europe, in addition to the United States.
Inside the company itself, colleagues had to be educated on the implications of medical device registration, with the expectation of additional workloads later in 2016 and into 2017. New essential requirements would emerge, along with scrutiny reviews and new clinical investigation requirements, translations and summaries.
For all parties, including the company’s senior executives and many of its senior staff, registration has held serious challenges. Continuous education together with increased marketing has had budgetary implications, and there has been pressure to keep up to date with activities in other countries during this process.
On the positive side, the company noted that it has allowed new strategic decisions to be made, has potentially reduced the number of competitors, provided opportunities for market expansion and enhanced patient safety and product performance.