On the 5th of May last year, the new European Union Medical Device Regulation (MDR) was published in the Official Journal of the European Union. The new regulation is associated with a three-year transition period following its publication and, therefore, will enter fully into force in 2020. With more than twelve months already under the belt, the introduction of the MDR requires and continues to command significant attention by medical device manufacturers to ensure their new products (but also their existing product portfolio) can remain on the market. Critical elements to achieving this objective are planning and foresight to pre-empt unforeseen hurdles along the way, but how much has been achieved since last May?
 
While the three-year transition period is without doubt a steep hurdle, even without this challenging deadline, it seems that far too many businesses are still leagues behind in adopting the new MDR. One factor may be the unwillingness to face the fact that deadlines are looming, which is fueled by rumors of possible extensions. Although the European Commission (EC) is unwilling to confirm there will be any extensions for fear of lulling the industry into a false sense of calm, the extended EC certificate validity period, coupled with the necessary re-designation of new Notified Bodies (NBs) in Europe are likely to extend the actual implementation timeline.
 
Notified Bodies
In fact, in Europe, the number of NBs has reduced by a staggering 20 percent over the last two years with likelihood that the situation will be further exacerbated as increasing scrutiny is applied to their processes by their respective Competent Authorities. This is a result of recent highly publicized safety issues relating to medical devices that had been allowed to enter the market. As a result, new NBs will have to be designated while the few remaining will undoubtedly struggle to satisfy growing demand from manufacturers wishing to certify compliance with the new directive. To add to this pressure, NBs are also now required to perform unannounced inspections every 5 years. The worrying result may be that products cannot be put on the market fast enough because NBs are too burdened to carry out the necessary audits—a damaging result for businesses that lose competitive advantage and sales as well as patients that may rely on specific devices to improve their lives.
 
MDSAP and ISO 13485:2016
A year later and the MDR is in force, but it is clear that NB capacity issues are not going to be a problem for some time as manufacturers are proving to be unpredictably slow in addressing the requirements of the MDR. The reasons are numerous, but first and foremost, many manufacturers are still working on achieving compliance with ISO 13485:2016 or have embarked on complying with the multi-country program MDSAP (Medical Device Single Audit Program), which have earlier regulatory deadlines than the MDR.
 
What has clearly not been taken into consideration is the fact that improving processes and auditing internally will help manufacturers achieve compliance across the board with all these regulations. Taking a piece-meal approach that tackles one regulation at a time and that rests on the hope that there will be an extension is a short-sighted and ineffective approach that doesn’t make the most of resources. A full revision of products and paperwork can only be beneficial in ensuring that compliance is more rapidly achieved across the board and that your business is ready for any future regulations or any unannounced audits.
 
To provide a measure of the opportunity businesses could be missing if they fail to address compliance with the MDR in a timely fashion, we’ve developed a Market Opportunity Value (MOV) model that demonstrates the potential annual revenues achievable for MDR-compliant manufacturers, or conversely, the scale of the market penalty for non-compliance is available. The figure sits at a staggering $16.5 billion.¹ Manufacturers would therefore do well to seek the assistance of expert professionals to help them build a plan for their compliance with MDR earlier than their competitors to benefit from first mover advantage and avoid experiencing any bottlenecks or delays when the rest of the industry starts to address the issue and demand the attention of NBs.
 
Reference
¹ The total market values from which it is derived are based on the latest verified medical market value estimates from a variety of established analysts8. The countries selected represent the top ten EU countries by nominal GDP, plus Switzerland