On 20 September 2016, the Council of the European Union accepted the European Parliament’s first reading position in relation to the proposal for a new Medical Devices Regulation (MDR), paving the way for formal adoption of the MDR, which is expected to take place in early 2017. This article focuses on the changes that will be brought about by the MDR and makes a number of practical suggestions for what industry stakeholders might want to consider in preparation for those changes. Whilst a further regulation, the In Vitro Diagnostic Devices Regulation (the IVDDR) is also undergoing the legislative process in parallel with the MDR, further discussion relating to the IVDDR will be the subject of a another article.
The existing laws governing the medical devices industry date back to the 1990s and have recently come under harsh criticism as a result of a number of medical device scandals. One such scandal related to a French manufacturer – Poly Implant Prothèse (PIP) – who had been manufacturing breast implants using industrial silicone rather than medical grade silicone contrary to its regulatory approval resulting in harm to thousands of women worldwide. In addition to the weaknesses of the current framework as demonstrated by these scandals, the need for the regulatory framework to develop with the extensive scientific and technological innovation that has taken place since the implementation of the current legislation, has highlighted the need for modernisation of the current framework.
The new MDR will modernise the current regulatory framework governing medical devices with the aim of ensuring greater safety and quality for patients, increasing the transparency of the industry and improving the traceability of medical devices on the market. The MDR will replace the two existing directives – the Medical Devices Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC) – meaning that there will be no requirement for implementing legislation, resulting in greater harmonisation and an increase in much-needed consistency across the internal market.
Despite the British public’s vote to leave the EU in the recent referendum, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has continued with business as usual, stating that it would continue to make “preparations to implement proposed new Regulations for Medical Devices”. Irrespective of how the issue of Brexit evolves, the MDR will take effect in EU Member States three years after its entry into force, which according to current estimates should take place in early 2017. This transitional period should therefore come to an end in 2020, providing medical device manufacturers with a three-year transition period to make the changes required to comply with the new framework.
Whilst representing a tightening up of the current system rather than a wholesale change in the approach to medical devices regulation, the MDR will introduce many changes that all industry stakeholders ought to be aware of to ensure a smooth transition to operating under the new regime. We highlight some of the major changes that can be expected below.
Extension of the scope of the MDR
A significant number of definitions will change under the MDR such that the scope of the regulation will be extended. In addition to changes to the definitions for accessories, custom-made devices and products based on human cells or tissue, the scope of the MDR will
be extended to cover specified products that do not have a medical purpose but which have similar characteristics and a similar risk profile to medical devices. Such products include non-corrective contact lenses, such as coloured contact lenses for cosmetic use, and other implants and fillers for aesthetic use. As a result of their inclusion under the MDR, such cosmetic products will now have a much greater regulatory compliance burden, such that it is likely that only the best and safest products will remain on the market. With regards to changes to other definitions, manufacturers will have to carry out a gap analysis across their portfolio and develop a strategy for the approval of devices that fall under the new definitions, as required.
New classification rules
New rules for the classification of medical devices into different risk categories will be introduced, including rule 21, which will allow for medical devices to be composed of “substances intended to be ingested, inhaled or administered”. Read together with the definition for “medical device”, rule 21 clarifies that medical devices can exert their effect by pharmacological, immunological or metabolic means, as long as this is not the medical device’s principal mode of action. Rule 21 therefore provides a degree of legal certainty in what was previously a very blurred borderline between medical devices and medicinal products. It is foreseeable that as a result of this clarification, the number of in-house clinical trials for substance-based medical devices will increase under the MDR.
More stringent testing and reporting requirements
The MDR will provide an EU-wide regimen for the clinical assessment of medical devices, thereby replacing the diversity of testing that has emerged under the current directives. Under the new regimen, clinical assessments will be required to provide evidence on safety and performance tailored to the risk category of the device in question and each manufacturer will be obliged to have a full technical file available. In addition to new medical devices, devices currently on the market are not exempt from the prospective changes and will need to be re-evaluated and re-approved in accordance with the MDR. As a result, manufacturers will need to perform gap analyses for each of their products to identify what further clinical evidence will be required under the new regime and ensure that such further clinical assessments are carried out in time for re-certification before the end of the transition period.
Once on the market, manufacturers will also be under an obligation to carry out further clinical evaluations, known as post-market clinical follow-ups (PMCF), and produce periodic safety update reports (PSURs) throughout the lifetime of a device. These post-market surveillance and vigilance requirements are continuous and are designed to confirm the safety and performance of a device throughout its expected lifetime and to allow emerging risks to be detected. As a result of these new obligations, it is likely that manufacturers will need to revaluate and amend their current post-market surveillance plans to ensure that they comply with the new regime.
Changes to Notified Bodies
Notified Bodies will have enhanced powers under the new framework such as the power to conduct unannounced inspections and carry out product testing, but will also be subject to a higher degree of scrutiny by the competent authority of their Member State and potentially also the Commission and a body of experts. However, Notified Bodies under the current regime will also require re-notification before they are able to approve medical devices under the MDR and it has been estimated that as many as 50% of current Notified Bodies will not be re-notified or may not be notified for the same scope as previously. This, together with the requirement for re-notification and re-certification of all medical devices, suggests that manufacturers can expect to encounter delays in getting their products (back) on the market. Manufacturers should begin to consider planning for this scenario and where possible begin consulting with their current Notified Body to evaluate potential compliance issues and where necessary, identify a new Notified Body in the event that their current Notified Body is not re-notified or has their scope reduced under the MDR.
More robust quality control systems
The new regime will see the introduction of an obligation on all manufacturers to have available within their organisation at least one “qualified person” i.e. a person who possesses expert knowledge in the field of medical devices and who is responsible for regulatory compliance for that organisation. In addition, the MDR imposes regulatory responsibility – the duty to check compliance of devices and to initiate corrective action – on each party in the supply chain, including importers and distributors, as well as manufacturers. It is likely therefore that current distribution and supply chain agreements will have to be amended to take this increased level of regulatory responsibility into account. These major changes to the regulatory responsibility for medical devices are intended to improve the quality of medical devices on the market and economic operators at all stages of the supply chain will have to take note of their new obligations, amending and implementing their quality management systems accordingly.
Improved transparency and traceability
The MDR will provide for the further development of the European databank on medical devices (EUDAMED) which will provide economic operators, healthcare professionals and the public with more information on medical devices in the EU. Manufacturers will be required to assign each device a Unique Device Identification (UDI) which will be held on EUDAMED, together with further data on device registrations, clinical investigations and market surveillance. UDIs will improve the traceability of medical devices, allowing efficient recall of problematic devices as well as the identification of who devices were supplied by or to. In addition to amending current manufacturing processes to allow for the marking of devices with a UDI, manufacturers of high risk and implantable devices will also be required to provide further information relating to the safety and clinical performance of such devices for inclusion on EUDAMED. These changes to EUDAMED will increase the transparency of the industry and provide important information to all users of medical devices.
The MDR provides for “sunshine compliance” which allows for the (re-)certification of medical devices under the new regime prior to its application (i.e. during the transitional period) in derogation of the current legislation. However, until the MDR is published in the Official Journal of the European Union, the dates of the transition period will not be fixed and so it is not yet clear when manufacturers can start taking steps to comply with the MDR. Nevertheless, manufacturers should monitor the final stages of the legislative process closely as this will allow them to start complying with the new regime as soon as the transitional period begins so that they can maintain or obtain access to the medical devices market.
It is clear from the above discussion that the new framework will impose more stringent regulatory requirements on the medical devices industry which will inevitably require manufacturers and other economic operators to reappraise and adjust their operations to ensure compliance with the new regime. However, it is likely that those who have been complying with the spirit of the current framework by implementing guidance as it becomes available should be in a good position to take advantage of the three year transitional period during which sunshine compliance is allowed. Nevertheless, it is clear that the retention of the CE marking system rather than the introduction of marketing authorisations in a fashion similar to the regulatory framework governing medicinal products shows that the new MDR represents an evolution, rather than a revolution of the current regulatory framework.