The new European medical devices and in vitro diagnostics regulations (MDR and IVDR) have been a long time coming, however, they are now almost finalized. Final draft texts were agreed by the EU in June 2016 and are expected to be adopted in the first quarter of 2017.

According to the EU Council of Ministers, the regulations, which will cover devices from sticking plasters to orthopedic hips and pacemakers, and in vitro diagnostics (IVDs) from over-the-counter pregnancy tests to high-tech tests for HIV, will reinforce safety by strengthening the rules that allow devices onto the market, and tightening surveillance on launched products.

The regulations replace existing directives and will introduce some major changes for device and pharma manufacturers who buy-in delivery devices from contract manufacturers.  While there will be a three-year transition period for medical devices and five years for IVDs, this will pass quickly, so it is important that companies start working towards the new regulations as soon as possible.

Whilst many of the key features of the directives (CE Marking, Notified Bodies, technical file, classification based on risk) remain under the regulations, there are some key changes and substantially reinforced requirements which require planning and investment on the part of manufacturers to ensure they can continue to market their devices in future.

Some classification changes may mean that devices are up-classified and subject to a different and potentially stricter conformity assessment.  Manufacturers should carefully assess this and whether they can continue to comply.  For these and other devices with low sales volumes, manufacturers may wish to evaluate the economic viability of compliance to the new regulations.  This may be particularly relevant for IVD manufacturers who are facing a major increase in the proportion of devices which will need review by a third-party Notified Body.

Clinical evidence continues to be a focus of the body of documentation manufacturers must collate to support safety and performance claims.  Some major changes in equivalence and a requirement to show access to clinical data on competitor devices, claimed to be equivalent, will challenge many manufacturers.  Any new clinical data requirements will require investment in time and money, and may risk delaying bringing devices into compliance.

Post-market, manufacturers will face additional challenges in the form of shortened time-lines for reporting incidents, and a new requirement for periodic safety update reports.  Investment in personnel and training will be required to ensure a robust system to meet these requirements. 

Manufacturers must assign an individual to regulatory compliance who is responsible for product release, clinical products and vigilance.  This is a new requirement in the device world, although similar to the QP in the pharma world. 

The above are just some of the key changes being introduced in the regulations.  It is important to also note that many additional regulations need to be prepared to support and give detail on the requirements of the regulations.  As these will be issued over the coming years, manufacturers need to remain vigilant to ensure compliance with the details still to be issued.

These changes are happening in parallel with other major changes in the medical device world.  The quality system standard EN ISO 13485, which is a de facto GMP requirement for most manufacturers, has just been revised for the first time in 13 years resulting in some major amendments.

Equally, we are seeing a reduction in the number of Notified Bodies available to certify medical devices and manufacturers’ quality systems, meaning a reduced capacity and in some cases delayed audits, reviews and certifications.

Facing the challenges

The new regulations have time and cost implications for companies – larger companies will have a lot of products to assess and classify over a relatively short period, and small companies may not have the resources or the expertise in-house to handle the process.

The most important thing for companies to understand is that these changes are on their way, and starting early will allow them as much time as possible to complete the process and ensure optimum regulatory and commercial standing. The next step is to assess the amount of work required to be compliant and then to ensure that there is a budget in place to cover the work required.

Because of the complexity and urgency of the process, collaborating with expert and experienced partners will provide confidence in the outcomes. Quintiles Advisory Services has specialists across Europe who have experience of in vitro diagnostics and medical devices in national and global markets, and have followed the evolution and development of the new European regulations in detail.