In 2017, the European Union (EU) instituted the Medical Device Regulation (MDR) as the next phase in the medical device regulatory framework in order to replace the current Medical Device Directive (MDD). The MDD has been in effect since 1993, and was devised in order to harmonize disparate laws, regulations and requirements pertaining to medical devices. Devices which conform to the stipulations put forth by the MDD are awarded the CE mark which lawfully allows for the sale of said device in EU countries.
We have been carefully following the EU’s medical device regulatory framework as our clients prepare for this challenging transition. The transition from the MDD to the MDR is complex and brings with it its own set of problems which can be difficult for start-up companies to navigate. Furthermore, the differences between the MDD and the MDR are not readily apparent.
Our consultants have dived deep into these issues and prepared this article for clients and potential clients to seek guidance from. We understand that the 23 articles, 12 annexes and 18 classification rules in the MDD can be complex to digest and we sincerely hope that you glean useful insights from the expert advice offered here.
Overview of the MDD
The first question which we commonly face from clients is “why?”. Why is there a pressing need for the MDD to evolve to the MDR? What weaknesses were inherent in the MDD framework which incentivized this transition? This is a good starting point from which the MDR can be better understood. The MDD framework was developed with two factors in mind – safety and performance. From non-invasive devices such as ambulatory blood pressure monitors, to invasive devices such as ocular contact lenses and cardiac stents, the MDD framework has ensured that medical devices remain safe since 1993. The MDD serves to harmonize the standards which benefits three main stakeholders – manufacturers, users and patients. It defines clearly the requirements for clinical testing, design, manufacture, testing, inspection, marketing, installation and the service of devices sold in EU member states.
The MDD can be broken down into 3 components:
i) Essential Requirements
ii) Classification Rules
iii) Conformity Routes
Essential Requirements (ER) stipulate the minimum requirements for the design and manufacture of medical devices and emphasise safety as an integral component of the design of the product – these can be found in Annex I of the MDD.
Classification rules enable the categorization of medical devices into 1 of 4 classes – I, IIa, IIb and III in ascending order of risk. Generally, class I devices are non-invasive and are low-risk, whereas class II and III devices are invasive and are medium to high-risk respectively. However, exceptions do occur and may be contingent upon the time period in which the device performs its intended function (transient, short-term and long-term). These nuances can be better appreciated by reading the 18 classification rules which classify your device appropriately.
The conformity route which contends with design and manufacture of the medical device. The classification of the medical device precedes the conformity route, as the latter depends on the former. The selection of the appropriate conformity route (of which there are several), is dependent upon the class of the medical device. Manufacturers must provide evidence that the medical device meets the ER by providing a Technical File (TF). The various routes of conformity assessment can be referenced in Annexes II, III, IV, V, VI, VII and VIII.
Despite the three components of the MDD which seek to prioritise performance and safety of medical devices, the MDR which came into force on May 26th 2017, significantly tighten existing controls to achieve this. New rules have been incorporated in order to reflect the current gold-standard for medical device regulation, which is invariably different from that in 1993.
The Medical Device Regulation – A Robust Change
The changes in the MDR are associated with a plethora of benefits. First, there is an enhanced protection of public health and individual patient safety. In particular, high risk devices (Class II and III) will be subjected to stricter pre-market controls. Rules governing the clinical evaluation plan (CEP), clinical investigation plan (CIP) and clinical evaluation report (CER) are stricter than in the MDD.
In addition to strengthening existing rules, there is also a greater push for transparency by the MDR. A comprehensive EU database on medical devices, known as the EUDAMED will be furnished by 2020, and aims to publicly display information pertaining to the entire lifecycle of medical devices which have been CE marked. Class III devices which are high-risk will be subjected to greater scrutiny and will have summaries on their safety and performance which can be publicly accessed. Furthermore, devices which contain substances that are introduced into a patient’s body will be moved to higher risk classifications than was initially placed under the MDD. Additionally, the general definition of what constitutes a medical device is expanded under the MDR. Devices which were once considered non-medical or cosmetic are now covered by the MDR (e.g. liposuction devices, contact lenses and cleaning/sterilization materials).
To improve identifiability and traceability of medical devices, the MDR also introduces a novel device identification system based on a unique device identifier (UDI). Patients who have implantable medical devices must be provided an implant card which contains vital information regarding the device which can be useful to both patients and healthcare providers.
To improve accountability, the MDR also includes a robust financial mechanism to adequately and appropriately compensate patients should a defective medical device be used.
To improve coverage, the MDR will also constitute a single directive that replaces not just the MDD, but also the Active Implantable Medical Devices (AIMD) and In-vitro Diagnostic Directives (IVDD).
MDD à MDR Timelines
As a medical device manufacturer, the timelines concerning the transition from the MDD to the MDR may be confusing. In short, this transition period will complete by 26th May 2020. By this time, all manufacturers should have updated their Technical File with the relevant documentation concerning design and manufacture.
What this means for existing MDD CE Certificate holders is:
- Until 25th May 2020, MDD CE Certificates are valid
- From 25th May 2020 to 25th May 2024, MDD CE Certificates issued before 26th May 2020 will be valid
What this means for existing MDR CE Certificate holders is:
- Until 25th May 2024, devices with the MDR CE mark can be placed on the market
What this means for non-CE marked device is:
- From 26th May 2024 onwards, devices placed on the EU market must be certified under the MDR
With the above timelines in mind, manufacturers have a choice from now until 26th May 2020 to apply for the CE mark under the MDR or the MDD. The principal considerations governing this decision are complex. The decision to undertake the MDR or MDD for CE marking is extremely important and can have far-reaching consequences on the roadmap of a company and the lifecycle of the medical device, and should not be taken lightly.
Brexit and the MDR
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has reiterated guidance on the MDR in the event of a no-deal Brexit. A no-deal Brexit implies that the UK will leave the EU on the 31st of October 2019 and there would be no agreements in place regarding the relationship between the UK and the EU in the future. The MHRA has maintained that it would have a medical device regulatory system in place which mirrors the key elements of the MDR and will be brought into force in line with the existing transition timetable delineated above.
In the event of a no-deal Brexit, manufacturers can expect to make separate submissions to the MHR for medical device compliance (analogous to the CE mark). However, the content of the Technical File is not expected to be vastly dissimilar. Post-market surveillance will have to be scoped specifically to the UK and not the EU at large.
Positive development for patient safety
The transition of the MDD to the MDR is a welcome change, as it places a greater emphasis on patient safety, public health, transparency and financial accountability, and medical device traceability. It does not detract very much from the core components underpinning the MDD – the Essential Requirements, Classification Rules and Conformity Routes remain in place with additional safety introduced in the form of more stringent rules. Manufacturers should be closely aligned with the timelines reproduced in this article and decide on their regulatory strategy (i.e. MDD versus MDR).