When prompted with the question “What are the biggest challenges you are facing?”, 66% of senior management respondents to Emergo’s 2016 medical industry survey answered that changing regulatory requirements are affecting their companies the most. Somewhat related, the challenges of developing new products came in second with 45%.
The importance of adhering to standards in medical device development has always been crucial, resulting in business risks and challenges for medtech companies. With new regulations being imposed upon them by EU authorities in 2016 and going forward, medical technology developers are struggling to understand and to adequately prepare for upcoming regulatory changes.
Changing compliance landscape: ISO 13485:2016 and EU MDR
According to a Deloitte report, key considerations for EU regulators adopting new measures included the simplification of current rules; enhancing collaboration by harmonizing regulations; and establishing transparency and product traceability – all this with the ultimate goal of ensuring the safety of patients. Two major changes in regulations are ISO 13485 and the European Medical Device Regulation.
ISO 13485 is a standard that sets the requirements for a comprehensive quality management system in the design and manufacturing processes of medical devices. With ISO 13485 having received an update in 2016 to replace its 2003 version (going effective in March 2019), medtech companies already have a lot to adapt to.
In addition to ISO 13485’s facelift, European commissioners have also agreed on the final text of a comprehensive set of new measures regulating the medical industry. The new Medical Device Regulation (EU MDR) is intended to overhaul current legislation on active implantable medical devices (90/385/EEC) and on medical devices (93/42/EEC), as well as in-vitro diagnostic medical devices (98/79/EC). Therefore, MDR can be regarded as a new, all-encompassing industry standard affecting a huge portion of medical technology developers that is going to become mandatory by 2019-2020.
A closer look at updated medical device regulations
Thanks to the comprehensive nature of EU MDR, the regulatory landscape for the medical devices industry is definitely expected to improve. That said, preparing for the requirements of changing regulations does pose a difficult challenge for medtech developers. 61% of European respondents to the 2016 Emergo survey believed that obtaining regulatory approval for medical devices will be more difficult than it used to be, and 54% of them indicated some level of confusion with regards to changing regulations.
With all that uncertainty about how new regulations are going to impact them, medical device developers may find it hard to prepare for regulations by future-proofing their development and other processes today. Ensuring compliance will remain a complex challenge in terms of technology, hiring, processes, and change management, with medical device regulatory professionals expected to be in high demand going forward.
Below is a short summary of the implications of regulatory changes that medtech companies will be looking at in the near future:
ISO 13485:2016 – Medical devices – Quality management systems
The updated 2016 version of ISO 13485 contains requirements for companies to ensure their ability to provide medical devices and related services that meet the expectations of both users and regulatory bodies. The standard is applicable to companies involved in various stages of the medical device development lifecycle, including design, development, manufacturing, storage, distribution, installation, servicing & support.
In summary, the requirements of this updated standard stipulate the following:
- A risk-based approach to the safety and performance of medical devices
- Application of the standard throughout the development lifecycle and supply chain
- Updated requirements on software validation
- Thorough reporting to regulatory bodies, post-market surveillance
- Adequate planning and documenting of preventive & corrective action
EU Medical Device Regulation (MDR)
The new EU MDR applies to companies providing a wide range of medical devices and active implantable medical devices. The standard covers all sorts of devices from coloured contact lenses to diagnostic and “predictive” medical devices – meaning that almost all medical devices companies operating in the EU will be affected by the implementation of this new set of regulations.
Some of the key requirements of EU MDR are:
- The requirements around providing clinical evidence are becoming more rigorous. Medtech companies will be required to perform clinical investigations about the safety and performance of their products in proportion with the risks associated with those products.
- Companies must identify and appoint a qualified person to be in charge of compliance. In addition to that, post-market surveillance of regulatory bodies will also expand, with medical device development companies being subject to unannounced compliance audits by Notified Bodies.
- While complying with ISO 13485 is not a requirement of EU MDR, the new Medical Device Regulation requires companies to implement a comprehensive Quality Management System (QMS), and ISO 13485 is an internationally harmonised standard covering this topic.
- Control over development and distribution chains will become stricter, with Unique Device Identification (UDI) labels (codes) ensuring the traceability of products throughout the supply chain. Medtech professionals also expect the Eudamed (European Databank on Medical Devices) to be expanded for ease of identification and traceability.
Preparing for a shifting European medtech regulatory landscape
EU MDR is widely expected to come into effect in 2019-2020, and ISO 13486:2016’s transition period will end March 2019, giving medical device developers a transition period of roughly 3 years. Since ISO 13485:2016 and EU MDR cover a wide range of medtech companies, early adoption and preparation will give these organizations enough time to build the processes and infrastructure that will allow them to comply.
After understanding what new regulations mean to them, medical device developers are encouraged to assess their current product portfolio, and to review their processes and supply chains. Based on the results of this analysis, they will be able to devise a strategy and roadmap for tackling the complex, cross-functional issue of compliance.
Expert help might be necessary for various aspects of this transition process. From a technological and process standpoint, Intland Software’s codeBeamer ALM is a proven tool used by successful medtech companies to implement mature processes that provide continuous compliance in medical device development. To find out how medical technology leaders benefit from the use of codeBeamer ALM, download our Medtronic case study below, or request a 1-on-1 product demo.