New EU Regulation Transition - Do we have the time?

The advent of the new EU regulations for medical devices (2017/745) and In Vitro Diagnostics (2017/746) is a move in the regulatory framework of Europe which should be broadly embraced. Sure, we can all point to areas where the wording and interpretation leaves a lot to be desired and I am sure there are areas of both regulations which will be improved over the years as we get familiar with the new paradigm. I also have to applaud the gradual unification of regulation in the devices and pharmaceutical sectors, let's face it, there is a great deal that both camps can learn from each other in terms of best practices, testing etc.

With all these positives then, what am I talking about. RESOURCES!!!!!! with no arguments as to whether these regulations are a good idea, I have to ask myself who did the industry impact assessment which has driven the transition timelines currently enshrined in the regulations?

As an industry we are not the best in developing and bringing new talent into the technical disciplines of our industry, this is especially true of Quality, Regulatory and Clinical professionals and unfortunately these are the resources that this transition rely on. Unfortunately however, we have no clear educational route through or tertiary education systems which are specifically preparing people for careers in this sector. We can already see the consequences of this resource GAP impacting all levels of industry. The particular consumers of this scarce resource are(in no order of preference)

1.    The Medical Device Coordination Group (MDCG) a crucial actor in the framework of the new regulations with multiple advisory and review responsibilities across both of the new regulations. Including participation in the re-certification and designation of notified bodies (NB) under the provisions of the regulations.

2.    Industry, especially small to medium manufactures (SMEs) need flexible resources to support them through this transition, usually with the support of consultants (Expensive)

3.    Notified Bodies reviewers and auditors.

We are already seeing the effects of resources in the market place with a resource based initial culling of Notified Bodies. We are also seeing a sharp down-turn in many innovative companies ability to bring products to market. Many large Notified Bodies have extended technical file and quality systems review periods to times of up to a year. Some are being forced to close their doors to new business completely because of technical constraints.

So what do we do?

It is obvious that we are all competing for increasingly scarce and expensive technical resources, It is equally obvious that the current resources are finite. In this situation, something has to give! In this case we have to recognise that the template for transition currently in the regulations is unlikely to be deliverable without significant potential impact on the delivery of healthcare and healthcare innovation to patients in the EU. I think we also need to recognise that the level of compliance applied in the new regulations must impact healthcare delivery costs! Given these points there appear to be 2 action areas:

• an urgent examination of the realistic implementation timetable for the new regulations and a reset on the expectations of this change.
• development and support of tertiary education programs to generate an appropriate resource pool which can support the compliance of European Industry going forwards.

We would be very interested in your feedback and thoughts on this article.

Written by Richard Young richard.young@sensus-group.com

Published by Ben Jaggers ben@sensus-group.com