In less than a year, the 26 May 2020, the new European Medical Device Regulation (MDR, (EU) 2017/745) will fully enter into force, after the three years transition period from its approval on 5 April 2017; the other new regulation (EU) 2017/746 on In vitro diagnostic medical devices will also come into force on the same date. A full guidance to the different aspects of the new framework, together with relevant links to explanatory documents, can be found on the dedicated webpage of the European Commission.
Compliance with the new rules to obtain the CE certification will become compulsory from 26 May 2020; previously released CE certificates will maintain validity for five years from their issuance, and devices already on the market at this data can be sold up to 25 May 2024, when their CE certificates will loose validity. But in case of “significat changes” to the devices after May 2020, the passage to the new regulation shall occur immediately.
The reasons for a new regulation
The adoption of the new rules has completely redefined the framework for the development, production and distribution of medical devices in the European Union. The new vision has tried to capture the rapidly evolving field of medical technologies, that includes a very big variety of different products, each one with its own peculiar characteristics. The final objective is double: improving the overall safety of the devices marketed in the EU, as well as boosting the competitiveness of the European medtech industry globally.
Even if the picture is quite clear and the Medical Device Coordination Group (the MDCG) – an expert group made up of experts of the national competent authorities – is supporting the EU Commission and member states in the implementation of both regulations, many details are not yet fully published. This uncertainty reflects on the industry to be able to prepare in advance for the final transition to the new legislation.
The main features of the new MDR regulation
A regulation, and no more a directive: the EU Commission has selected this type of legislative tool so that it has to be automatically implemented by member states without the possibility of modification. The different interpretations at the national level of the previous directives were one of the main issues limiting their standardised application across Europe.
The new regulations have reclassified both medical devices and in vitro diagnostics. Stricter ex-ante control via a new pre-market scrutiny mechanism with the involvement of the MDCG has been put in place for high-risk devices. The criteria for designation and oversight of Notified Bodies have been revised; according to Commission Implementing Regulation (EU) 2017/2185, starting from 26 November 2017 conformity assessment bodies have to apply for designation as notified bodies under Regulations (EU) 2017/745 and 2017/746.
A better transparency of the development process for a new device has been pursued by the reinforcement of rules on clinical evidence and product traceability (referred to some aesthetic devices with the same characteristics and risk profile as analogous medical devices, e.g PIP silicone breast implants). An EU-wide coordinated procedure for authorisation of multi-centre clinical investigations and the strengthening of post-market surveillance requirements for manufacturers – including an improved coordination mechanisms between member states – are expected to support this new vision both in the pre- and post-launch phases of the devices’ life cycle.
The establishment of a comprehensive EU database on medical devices and the use of the Unique Device Identification system (UDI) to trace the products are the basis of the improved coordination mechanisms between different countries. All information on implanted devices are now provided to patients by the “Implant card”.
Open questions looking for answers
In a post on Greenlight Guru, Jon Speer defined the fundamental questions that companies should keep in mind while affording the transition to the new rules governing medical devices.
Starting from the need to update the legislation to new and emerging technologies: the old MedDev directive dated 1992, when apps and advanced software solutions were not available. The ageing of population was also not so dramatic at that time. The increasing complexity of both the technology and the society is reflected in a much more complex structure of the new MDR compared to the 1992 directive. The previous Active Implantable Medical Devices Directive (AIMD), for example, is now included in the regulation. The picture is further complicated by the subsequent publishing of 42 implementing acts and 12 delegating acts, aimed respectively to clarify and amend certain aspects of the regulation.
Not only softwares intended for medical applications are now considered medical device: the MDR extends the definition to certain products used to clean, disinfect, or sterilise medical devices, and products used to control and support conception. It may prove hard – on this basis – to correctly classify a new product under development. In this respect, Annex XVI of the MDR lists some groups of products without an intended medicinal purpose but that are now considered medical devices ex article 1.2: contact lenses, for example, substances or items for facial dermal filling (both of them being previously considered simple cosmetic products), or equipment intended for brain stimulation.
Only Class I devices are exempted from the auditing of their Quality Management System (QMS) by a notified body. The QMS shall comply to the requirements listed under the “General Obligations” specified by article 10 of the MDR, and shall be supported by the availability of a quality manual and all other documentation demonstrating auditing and validation activities. The QMS has to be verified and certified by a notified body, and it shall be fully applied starting from 26 May 2020. The ISO 13485:2016 standard on Quality Management Systems for medical devices offers manufactures a full picture to help them structure the new QMS. The Medical Device Single Audit Program (MDSAP) is another useful tool offered by many notified bodies, and it allows to access different markets with just one audit.
The device identifier (DI) and the production identifier (PI) are used to identify each batch of a certain device. Data on product registration, clinical studies and post-marketing surveillance will feed the centralised EUDAMED database of medical devices marketed within the EU.
Other changes derived from the MDR
The equivalence criteria to other similar devices already on the market can no longer be used by manufactures, explains Kim Trautman, NSF International executive vice-president, in an interview on Verdict Medical Devices. The result is that more clinical experimentation shall be needed, as it will no longer be possible to refer to data published in the literature and referring to competitors.
Issues might arise from the application of the risk management criteria required by the MDR, as if it would not be possible to reduce “as much as possible” the risks connected to a certain device, they have to be listed in the labelling or in the instructions for use. Reporting the clinical outcomes in the post-marketing phase may also pose some challenges to manufactures. “To meet these new requirements, manufacturers must break down the silos that traditionally exist between regulatory affairs and quality assurance”, says Trautman in the interview. This task may be difficult to achieve for many medtech companies, that are traditionally less structured compared to the very highly regulated environment typical of the pharmaceutical industry. Thus, a strategic decision may be to outsource some activities, or to keep all the process within the company.