William Fry’s Charleen O’Keeffe goes through everything you need to know about upcoming changes to medical devices regulations in the EU.
The new Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR) represent a long-awaited strengthening of the European regulatory system for medical devices. Divergence in the interpretation of the current directives, scandals involving medical devices and considerable advances in medical technology prompted their introduction.
Both regulations, which are set to become fully applicable on 26 May 2021 and 26 May 2022 respectively, replace the current directives that have been in place for over 25 years. While the medtech industry has positively welcomed this regulatory overhaul, preparing for it is a costly exercise, both financially and in terms of its imposition on management time and resources.
Preparing for and implementing the new medical devices regulations presents a challenge, not only for manufacturers, but for every entity within the medical device supply chain including authorised representatives, distributers and importers.
What are the new medical devices regulations?
The new regulations represent a fundamental revision of the directives and aim to establish a robust, transparent and sustainable regulatory framework for medical devices, ultimately seeking to ensure a high level of safety for device users and patients.
The scope of the regulations has changed and now extends to all economic operators in the supply chain. Traditionally, compliance with regulatory obligations and responsibilities were the remit of device manufacturers. These responsibilities are now shared with distributers, importers and authorised representatives, not least of which are burdensome labelling and post-market surveillance requirements.
Another key aspect of the regulations is new classification rules for medical devices and in-vitro diagnostic devices (IVDs). The new rules expand the range of products that are subject to external certification assessment. In addition, examples of aesthetic products that will now be considered a medical device under the MDR are dermal fillers, collagen implants and skin resurfacing equipment.
Under the IVDR, IVDs will now be graded into four categories in accordance to the risk they pose to health and safety, from Class A (low risk) to Class D (high risk). Under the IVDR, most IVDs will be required to undergo assessment and certification by a notified body prior to being placed on the market.
Putting this change into perspective, just 10pc to 20pc of IVDs were subjected to an assessment by a notified body under the current directives. The IVDR classification regime flips these figures on their head and will require 80pc to 90pc of IVDs be assessed.
Will this shift cause bottlenecks?
Given the new regulations have broadened the scope of medical devices subject to compulsory conformity assessments and the low rate of redesignation of notified bodies, the European medtech industry is justifiably concerned that a device certification bottleneck will result in a shortage of devices on the market.
As the only Irish notified body in the medical device space, the NSAI’s approval under the MDR is significant because it ensures continuity of certification for manufacturers that depend on its services. It also upholds Ireland’s reputation as being a centre of excellence and a hub for medical technology companies.
Regarding the IVDR, the NSAI has confirmed it is currently progressing its redesignation application with the European Commission and the HPRA. However, due to delays caused by the Covid-19 pandemic, it is unlikely to obtain approval this year, but the body hopes to achieve redesignation status by the second quarter of 2021.
What other changes will have a big impact?
A key part of the effort to adequately protect persons injured due to defective devices under MDR is Article 10(16). The IVDR equivalent provision can be found at Article 10(15).
For the first time, these regulations put a statutory obligation on medical device manufacturers to have sufficient financial coverage in place to cover product liability claims arising from defective medical devices.
Under the new regulations, the basis for assessing ‘sufficient financial coverage’ includes the risk class, the type of device and the size of the enterprise.
Thus far there has been little guidance on what types of financial coverage are acceptable (eg insurance or a financial institution’s indemnity or warranty), the potential maximum amount of financial coverage, and the party responsible for assessing and adjusting financial coverage.
What are the first necessary steps toward compliance?
It is fundamental that medical device companies act now to ensure compliance with the new medical devices regulations. Five initial key preparatory steps include:
- Reviewing your medical device portfolio – although medical devices and IVDs continue to be certified and placed on the market under the old system, companies are advised to be proactive in adapting to the requirements of the regulations, to avoid unnecessary approval delays and market shortages
- Identify distributors and importers in the supply chain and establish responsibilities
- Designate an authorised representative and agree a mandate
- Review all intra-company agreements and agreements with third parties
- Consider taking out liability insurance
Charleen O’Keeffe is a partner at William Fry and a member of its life sciences group, specialising in intellectual property and regulatory law.
To assist companies to navigate the new MDR and IVDR regulatory regime, William Fry has published a one-stop shop MDR and IVDR resource which consists of a user-friendly publication of the new regulations with easily accessible tabbed annexes and tables of equivalence. As the implementation dates of the MDR and IVDR approach, William Fry will continue to publish guidance and briefings here.