Mapping the pathway

The adoption of the new EU regulations on medical devices has been a long time coming but they are now finally here, and manufacturers need to act now in order to complete the necessary processes to ensure optimal regulatory standing.

After 5 years of drafting, the new Medical Devices (MD) Regulation (2017/745) and the In-Vitro Diagnostic Devices (IVD) Regulation (2017/746) have been published and the extent of the changes that all manufacturers will be required to make in order to affix the CE Mark to their devices under the regulations are now known.

The new regulations will impact every device manufacturer wanting to provide devices to the EU market and the respective three and five year transition periods for medical devices and IVDs will soon pass. For any device requiring Notified Body (NB) intervention (all devices with the exception of MD Class I and IVD Class A) the re-designation process for NBs to grant certification under the regulations will consume 18 – 24 months of the transition periods. On the other hand, some certificates to the directives granted during the transition period will be valid for 4 years following the date of application of the regulation (May 2020 for MDR and May 2022 for IVDR).So in order to ensure a successful transition, manufacturers need to act now, considering a number of key steps for implementation:

  • Read the regulation carefully, being aware that there will be more detailed regulations coming along to support key aspects, such as vigilance, devices without a medical purpose, classification of IVDs
  • Calculate the optimum time for your company to move over to the regulation, given where you are in the audits and certification cycle under the directive
  • Liaise with your NB to understand its timetable for re-designation under the regulation. If you are considering switching NBs in any event or specifically for the regulation — make sure you are in the queue for your new NB. Lack of NB capacity is a major concern, so don’t get caught out
  • Consider your portfolio and work with marketing to identify products which can be retired
  • Identify required clinical evidence for all your products and work on a plan to supplement with new data
  • Revise the format and content of all your technical files 
  • Start revising vigilance and post-market surveillance procedures, especially to take account of the new 15 day vigilance reporting time for most incidents
  • Plan for labelling changes, aiming for just one round of re-labelling.

IVD manufacturers face a particular challenge with the new regulation, the impact of which is huge. It is estimated that 80 – 90% of all IVDs will need some level of NB intervention, compared to only around 10 – 20% under the directive. And for companion diagnostics a large number of assays that were self-declared under the IVD directive are moved to Class C under the IVD regulation, requiring NB assessment for the first time. The IVD industry will be competing for the same resources as the MD industry. The five year transition should not allow IVD manufacturers to be complacent. The comparatively higher hurdles for IVD manufacturers mean much more work, so the process needs to begin now.

Supplier sync-up

There is another group that needs to pay special attention to the regulations to avoid being caught out. Virtual manufacturers using contract manufacturers and biopharma companies that rely on partner companies for drug delivery devices and companion diagnostics need to ask the right questions to ensure that these suppliers are also preparing for the MDR and IVDR. The plans for both the product brand owner and the supplier have to be synchronized to ensure product availability is maintained. In cases where different NBs are used at the legal manufacturer and supplier, there may be delays if the NB designation and transition timings to the MDR and IVDR differ.

It is also important not to forget the ripple effect of changes to CE Marking documentation on other registrations outside the EU, which may rely on CE Marking.

All this is happening in parallel to some key quality changes. Manufacturers have until February 2019 to transition their quality systems to the 2016 version of ISO 13485. And the Medical Device Single Audit Program (MDSAP) is going to be the only way to the Canadian market from 1 January 2019. The cumulative effect of all these regulatory and quality changes on device manufacturers coming together at the same time requires planning and investment in resources.

In order to navigate the complexities of the transition, manufacturers should look to engage with a partner with deep understanding of EU device regulatory. Through extensive experience, QuintilesIMS experts can provide support in areas such as strategic planning, technical documentation updates, clinical evaluation report preparation and provision of interim in-house staff, to help ensure a smooth transition over the next few years.