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The European Union will apply new regulations to the medical device sector in May 2020 under the EU Medical Device Regulation (MDR), a sweeping overhaul of the Medical Device Directive, which had been the regulatory standard in Europe since 1992. The MDR significantly tightens and increases pre- and post-market obligations for economic operators (i.e., manufacturers, distributors, importers, suppliers, subcontractors, assemblers and EU Authorized Representatives), establishes a database for all covered devices, and significantly expands the scope of covered devices and substances.
According to Travis Miller, general counsel at Assent Compliance, key objectives of the new regulation are:
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“Stricter lifecycle control of medical devices through enhanced quality management systems and the introduction of a Unique Device Identification (UDI) and a database
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“Introduction of a new risk classification system for in vitro diagnostic medical devices
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“Introduction of an implant card containing information about implanted devices for the patient
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“Improved coordination between EU Member States in the fields of vigilance and market surveillance
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“Increased oversight of Notified Bodies”
Medical device supply chains will see a dramatic increase in their regulatory burden through reporting, analysis of components and substances, and training and education in order to comply with the MDR. The EU has published guidance, including a step-by-step process for complying with the new regulations that is available for free.
What’s covered?
The MDR covers all medical devices, defined in Article 2.1 as “any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings” for one or more of the following specific medical purposes:
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“diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
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“diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
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“investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
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“providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations”
Article 2 goes into more detail regarding what is and is not a medical device, with the biggest changes being the inclusion of software (which did not exist as a medical device when the Medical Device Directive was drawn up) and devices that were previously considered to be cosmetic or aesthetic, as opposed to medical. Annex XVI provides a list of some of these additions to the list of covered devices:
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“Contact lenses or other items intended to be introduced into or onto the eye.
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“Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings.
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“Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing.
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“Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.
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“High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.
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“Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.”
Medical devices are classified by type, from “Class I – Non-invasive” to “Class III - Invasive Devices on the Body for a Long Time.” All classes except for “Class I – Non-Invasive” require notified body approval.
What are Notified Bodies?
A Notified Body (NB) in the EU is “an organisation designated by an EU country to assess the conformity of certain products before being placed on the market.” There has been a significant decrease in qualified NBs for the medical device sector, for a few reasons, including regulatory burdens, a difficult re-application process under the MDR, and labor pressures:
European Competent Authorities imposed new requirements on NBs to conduct random unannounced audits of their clients, an onerous stipulation imposed in the wake of the PIP breast implant scandal. Clinical data requirements have also become stricter under revised guidance document MEDDEV 2.7/1 rev 4, which increases scrutiny of clinical evaluations by NBs. Both of these factors, along with the 2017 passage of the European Medical Device Regulation (2017/745) and the In Vitro Device Regulation (2017/746), have also created a sizeable demand for qualified QA/RA professionals throughout the industry. These additional regulatory demands, combined with labor pressures, have in turn led to a burden that pushed some NBs over the edge. Many have decided that medical devices and IVDs are not an industry they want to serve any longer.
Currently, less than 10 NBs have been reinstated, down from more than 80 NBs just a few years ago. Many NBs were based in the U.K., primarily to serve the English-speaking market for exporters of medical devices (the U.S. accounts for more than half of medical devices imports into the EU), but a hard Brexit, coupled with the pressures mentioned above, has driven many U.K.-based NBs out of the market.
For organizations looking to comply with the MDR, the lack of NBs and the dramatically increased workload will present significant difficulties.
What is Section 10.4?
One of the most important articles in the new regulation concerns Annex 1, Chapter II “REQUIREMENTS REGARDING DESIGN AND MANUFACTURE,” Section 10.4: Substances. This section includes the requirement that devices may only contain substances that are carcinogenic, mutagenic or toxic to reproduction, or substances having endocrine-disrupting properties in a concentration below 0.1% weight by weight (w/w), unless justified following a thorough analysis pursuant to Section 10.4.2.
This section demands organizations dig deep into their supply chains and make a master chemical substance inventory list. When taking the MDR and other regulations (e.g., the EU Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH); the EU Biocidal Products Regulation; the EU CLP Regulation; and the Restriction of Hazardous Substances Directive) into account, this list includes more than 1,500 substances.
In addition, Section 10.4.5 includes requirements on labeling:
Where devices, parts thereof or materials used therein as referred to in Section 10.4.1. contain substances referred to in points (a) or (b) of Section 10.4.1. in a concentration above 0.1 % weight by weight (w/w), the presence of those substances shall be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances. If the intended use of such devices includes treatment of children or treatment of pregnant or breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances and/or materials, information on residual risks for those patient groups and, if applicable, on appropriate precautionary measures shall be given in the instructions for use.
Tip of the iceberg
The above are just a few of the major components of the new regulation. There are several things to be aware of, and there is a large burden of work to address, not least of which is made up of data collection and organization, the establishment of an ongoing quality management system, and the specter of mergers and acquisitions and their impacts on compliance.
The MDR is part of the EU’s push to encourage compliance across the board through the release of consumer- and environment-friendly regulations. The MDR could very well become the gold standard for medical device regulation in the world, forcing multinational companies to defer to EU standards when establishing their quality management systems. Not only does the regulation force global supply chains to conform, but it also positions any company in compliance with the regulation as a forward-looking organization prepared for a future in which the MDR sets the regulatory bar for sector innovation and growth.
Takeaways
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The EU MDR goes into effect May 2020. The impact of this regulation will change the way organizations in the sector do business going forward, and it will likely become the gold standard for global medical device regulations.
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The regulatory burden is high, and there are a limited number of Notified Bodies able to certify devices and help organizations through the process. An organization should expect a bottleneck if it hasn’t already certified its products.
