The Medical Device Regulation which was published earlier in 2017 is the hottest topic in medical device industry. While there is lots of information available, it can be difficult to tailor the information to your device and sector. In parallel, the new, significantly stricter European data protection law poses challenges for medical device manufacturers.

CTA Staff Writer Jisong Seo sat down with law firm partner Alex Denoon, Mariott Harrison, to ask what will be the major change in new medical device regulation and how companies can prepare for it. Denoon explains why it is important not just to comply with the new requirements, but also to consider the new requirements from a strategic perspective to obtain commercial benefit.

Jisong Seo: What are the biggest challenges facing the medical device industry?

Alex Denoon: The biggest issue for my clients are the two new regulations: the MDR (Medical Device Regulation) and the GDPR (General Data Protection Regulation).

The MDR entered into force on May 25, 2017, marking the start of a three-year transitional period for manufacturers selling medical devices in Europe. Crucially, the MDR does not include any provisions for “grandfathering” existing approved devices. Every device will need a new CE Mark.

Apart from a relatively small number of products that will be “up-classified,” the most significant changes in the MDR are:

  • Increased requirement for high-caliber clinical data (both pre-market and post-market)
  • A discontinuation of reliance on “equivalence” of one device with another approved device
  • Increased requirements for post-market surveillance (such as an annual update of Clinical Evaluation Reports)
  • A new “scrutiny” process for new “high risk devices”
  • Restrictions on the advertising of medical devices (an entirely new element to the regulatory framework)
  • Regulation of all MAIDs (Manufacturers, Authorized Representatives, Importers and Distributors)

The enhanced requirements under the GDPR need to be carefully considered, particularly in the context of gathering clinical data, but also throughout the product lifecycle, such as having adequate procedures in place to protect sensitive personal data held on devices or in systems.

JS: How can companies benefit from the MDR?

AD: While there will be a significant administrative burden for most devices, there will be opportunities. We recommend a comprehensive review of your entire product portfolio and revisit all aspects of each product: the claims, supporting data, PMS, classification, etc. For some products and companies, existing trials and registries may be “tweaked” to gather additional data to fill a gap.

Companies with large product portfolios need to assess all of their devices (with a particular focus on clinical data to support the new CE Mark and the ongoing need to monitor the devices in the real world). This will enable companies to allocate scare resources to products pragmatically. Some devices will not justify MDR compliance and those products are likely to be wound down during the transition periods. Others may benefit from a reduction in “me too” products which relied on equivalence and so should be prioritized.

Strategic opportunities range from M&A (Mergers and Acquisitions) and licensing opportunities through a review of product positioning and pricing. A small number of our clients will fundamentally change the way they market their devices, with some innovators considering entire marketing and reimbursement campaigns focusing on MDR compliance. Most of my clients are all actively prepared for the MDR changes already. Don’t forget that it will take extra years to enter the market and it will cost you more money if you are not prepared now.

JS: How do you expect the GDPR will impact the medical device industry?

AD: GDPR will make the approval and conduct of clinical investigations and trial significantly tougher. However, this is the tip of the iceberg: having adequate technological and organizational measures in place to manage the handling, encryption and protection of patient level data will be an ongoing and increasing burden. All sophisticated players in the sector are already increasing their focus on GDPR compliance in their relationships, contracts and audits.

Some people have suggested that EUDAMED may pose challenges. We do not anticipate that this will be a significant concern provided that the data has been anonymized before entry. If this is performed properly, then there should be no problem regarding GDPR. Given that EUDAMED is compulsory for all the manufacturers, we anticipate a professional approach by most users.

EUDAMED is a database of medical device products all around Europe and it used to be accessible for only few authorities. However, once it becomes a truly open public database it might become a useful tool assess the market.

JS: Is there any other things the industry should be aware of?

AD: The use of software in clinical trials of investigational medicinal products is increasing and challenging. Some CROs are developing clinical trial software to optimize the study and give it away free to their clients. However, some of these software programs are actually medical devices and should be CE Marked. For example, there is a software taking a photo of your arm during the trial that sends it to the database system automatically. It used to be easy to use in clinical trials but now it requires CE Mark for itself even though it is not used for commercial purposes. So manufacturers should be careful using software for their trials.

JS: How do you expect about the results of Brexit in clinical trials in the U.K.?

AD: Everyone is hoping or assuming only minor disruption in medical device industry caused by Brexit. If so, then there will be no big step outside of the current framework and we expect post-Brexit Britain to mirror the MDR in European market.

Even if it is a hard Brexit, data collected from the U.K. will be valid in European continent, so we don’t see a significant impact on clinical investigations at this stage. The location for a clinical investigation depends on cost, patient accessibility or opinion leaders more. Brexit should not cause major difference for clinical trial destinations.


*Alex Denoon is a Partner at London law firm Marriott Harrison