Drug-device combination product regulation Drug-device combination product regulation Drug-device combination product regulation

KPMG’s Global Strategy Group work with a variety of pharmaceutical, biotechnology and medical technology organisations to define their commercial ambition and develop innovative, market winning strategies. In a previous Medical Devices 2030 publication, we outlined a roadmap for success for the medical device industry which was focused on the core concepts of Reinvent, Reposition and Reconfigure.

One of the caveats of this publication was the uncertainty which lay ahead for the sector in Europe due to the impending implementation of the Medical Device Regulation (2017/745/EU) (the “MDR”). Following a delay, the MDR was implemented across Europe on 26^th May 2021. While the contents of this new regulation have been known by industry for some time, its cross-sector implications have yet to be fully realised.

In particular, it poses unique challenges for the pharmaceutical and biotechnology industry in Europe which place integrated drug-device combination products on the market. This encompasses form-factors we are all familiar with, such a pre-filled pens and pre-filled syringes containing medicines. These companies will now need to engage the services of a third-party entity, a Notified Body (NB), to perform a review of the device aspect of their product. In many cases, this will be a new interaction for all stakeholders involved.  

Previously, pharmaceutical and biotechnology companies’ needed to demonstrate the device component of their product was compliant with the Medical Devices Directive (93/42/EEC) (the “MDD”), a requirement which could often be achieved using a simple checklist approach. Now, Article 117 of the MDR amends the medicinal product legislation and stipulates that an application for a medicine with an integrated medical device will need to be supplemented either with a CE Certificate for the medical device, or, a “Notified Body Opinion” (NBOp), which summarises the NB review of that device. This documentation will be required by pharmaceutical and biotech players at the time of Marketing Authorisation Application.

The challenges this new process poses and its implication on a company’s regulatory strategy needs to be considered within organisations to anticipate impacts on future portfolio submissions.

Players in this space are faced with the prospect of navigating a complex regulatory ecosystem in which success is not guaranteed.

Obtaining an NBOp or a CE Certificate for the device component of a drug-device product may be a new process for pharmaceutical and biotechnology companies. They may be unfamiliar with the Notified Body ecosystem (distinct commercial entities operating across different geographic locations) and the documentation requirements (submission of a “Technical file” as opposed to a “Common Technical Document”).   Medical device, Pharmaceutical and Biotech players should be strategic in their preparation for and choice of Notified Body to ensure efficient interactions. 

Challenges aside, the implementation of the MDR offers several opportunities for the sector, both in terms of enhanced patient safety and increasing cross-sector collaborations leading to innovative products. 

The MDR will enhance transparency in the assessment of integral drug-device products. If a standardised approach to the NBOp is adopted and the level of detail provided to health authorities is sufficient, it could result in fewer queries being raised during the assessment process; this will function to ensure timelines can be met in what is an expensive authorisation process.

Patient safety is an underlying driver of the MDR. The necessity to obtain a CE Certificate or a NBOp for an integral drug-device product can only increase the level of assurance that the device is suitably safe and capable of performing its intended function when placed on the market. 

As the number of biologic medicinal products in development increases and large pharmaceutical/biotech players pivot towards digital health, the number of interactions between pharmaceutical/biotech companies, medical device manufacturers and notified bodies will have to increase.

This collision of industries, which are used to operating within their own silos represents an opportunity for increased innovation within the space. We are already beginning to see this type of innovation in new product offerings such as the Novartis Enerzair® Breezehaler® product, which is an inhaler for use in the treatment of asthma which is accompanied by a “digital companion” that includes both a digital sensor and associated app. This digital companion can provide the patient with information such as confirmation of inhalation and medication reminders as well as supporting data for therapeutic decision making. 

Companies which embrace these new regulatory frameworks, optimise their internal processes and build strategic relationships with other stakeholders in the process will possess a significant first mover advantage when it comes to ensuring a seamless route to authorisation.

For information on how we can help your business get to grips with the regulatory changes mentioned above, contact David Walsh. We’d be delighted to hear from you.