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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 26th 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.

Challenges

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

Adapting to emerging guidance:

The European regulatory network prides itself on the availability of comprehensive guidance for industry stakeholders. This guidance informs applicants on what information they should present to health regulators to demonstrate a new medicine is safe, effective and of suitable quality. Formal guidance from the European Medicines Agency (EMA) has recently been made available in the form of the  Guideline on quality documentation for medicinal products when used with a medical device while  Questions and Answers style documentation has also been published.
 
Whilst welcome, a potential applicant still faces a number of unknowns such as the scope of information to be included in the NBOp, the level of review this information will undergo in the health authority and how future post-authorisation changes to integrated medical devices will be handled.  Pharmaceutical and biotech companies should ensure they have adequate in-house or external expertise available to anticipate and adapt to future emerging guidance in this space.

Maintaining timelines in the face of capacity constraints:

The importance of regulatory timelines cannot be underestimated on the route to product commercialisation. It is currently anticipated that the CE Certificate or NBOp will be provided to health authorities at the time of submission, therefore companies will need to engage with the NB early to facilitate this process. As of August 2021, there were 22 Notified Bodies which can engage in the review of medical devices under the MDR. This represents a significant reduction in the number of these entities previously operating under the MDD (>75 NBs).  This considerable capacity reduction for a key stakeholder is a potential hurdle for the sector going forward. We expect that demand for NB services will likely increase further as there is an overall shift in the medicinal product landscape towards advanced therapies and digital health.  Without early dialogue with medical device manufacturers and Notified Bodies during the development phase of the medicine, pharmaceutical and biotech players risk jeopardising their submission timelines.

Engaging new stakeholders and establishing new processes:

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. 

Opportunities

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. 

Increased transparency:

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.

Increased patient safety:

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. 

Increased stakeholder interaction driving innovation:

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. 

First mover advantage

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.

Get in touch

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.