Quite a lot. To put it mildly.
From these dates the old directives consisting of the Medical Device Directive and the In Vitro Diagnostic Medical Devices Directive will no longer be applicable.
Instead, the regulations that govern the development of medical devices will either be the MDR (Medical Device Regulations,) or the IVDR (In Vitro Diagnostics Regulations).
The new MDR will apply from 2020, however, there is a five-year transition period for full compliance with the IVDR which started in 2017.
So, until 2022 IVDs can still be placed on the market under the current EU Directive OR under the new IVDR (if they are fully complied with).
Technology has transformed medical device development in the last few years. There are new products and solutions entering the market that were barely conceivable when the last set of regulations were introduced in the mid ‘90s. These include apps, consumer administered ‘life style tests’, new types of software, implantables, and deep brain stimulation devices.
These might not fit into the pre-digital definition of medical device, but still, if manufactured wrongly or used incorrectly, they could well injure or harm users and so need to be regulated.
Meanwhile, with a shift in demographics and an ageing population there is now a recognition of the greater need for transparency in medical device technical information to the general public to avoid accident and misuse.
As a consequence of the tightening up of regulations and the gaps closing in coverage there are whole new categories of device which will fall under regulation by the MDR in 2020, while the risk class of certain IVDs (Invitro Diagnostic devices) will be changed and in force by 2022.
In fact, it is thought, 80% of all IVDs will, in future, require certification by a notified body, instead of the 20% which need it currently. This, in particular, will increase the regulatory burden for some developers, who may have to undergo audit, and will certainly need to build out an auditable QMS to govern their development process and achieve their CE marking.
The MDR and IVDR define the term "medical device" as an "instrument, apparatus, appliance, software, implant, reagent, material, or other article" that is used for any of the following:
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The definition covers a broad range of existing devices. However, the MDR now specifies other types of products that need to obtain a CE marking. These include products used to clean, disinfect, or sterilize medical devices, plus devices used to control and support conception, whether through pharmacological, immunological, or metabolic means.
To close further loopholes Annex XVI also specifies that the following groups of products comply with the requirements of the MDR:
The IVDR introduces new classification rules based on the Global Harmonization Task Force System which uses four-risk based classes - Class A (low) to Classes B, C and D (highest risk).
As stated above, under the IVDR, most IVDs, will ‘up-classify’ into the higher risk Classes B, C and D requiring the involvement of Notified Bodies (independent certification bodies) rather than simple self-assessment.
Significantly, software and apps which are part of IVD instruments will become classified as SaMD (Software as a Medical Devices), and will now be included in the definition of IVDs and will be regulated.
The MHRA has published an interactive guide to help you determine the exact classification of your device. However, it is still a new area of medical device regulation, so it may be worth reaching out to the MHRA directly or even a Notified Body or two for their opinion.
The new MDR includes a requirement to incorporate a Unique Device Identification (UDI) that will help facilitate the traceability of all medical devices sold in the EU. Devices must be marked with a device identifier (DI) and each batch or production series of the product will be marked with a production identifier (PI).
The MDR and IVDR also introduces new databases for clinical investigations, product registration, and post-market surveillance. The EUDAMED database will be part of a system of several databases that allows Notified Bodies, medical device companies, consumers, regulators, and others to access the latest data on medical devices for sale in Europe.
For companies whose products do not currently come under the scope of medical device regulation or whose classification is going to change, there may be considerable effort required to start working within the tight Quality Management regulations specified in the MDR and IVDR, as well as preparing for and hosting system audits.
Both sets of guidance for MDR and IVDR, for example, state that manufacturers shall establish, document and implement a quality system, plus maintain its effectiveness throughout the entire device lifecycle. That is a huge task to undertake and may require specialist assistance.
There is a particular emphasis placed on the management functionality of that QMS for required procedures with document storage, post-market surveillance, and risk assessments of new and existing devices.
Life cycle management is being foregrounded by both sets of regulation and, as mentioned above, there are new requirements which cover this, for example, proactively monitoring device performance for re-certification, annual safety updates for higher-risk class devices, and rapid reporting of safety incidents.
The new pace and frequency of safety and performance reporting may require significant additional resources for companies. But, ‘baking in’ these ‘risk based thinking’ requirements to your SOPs can better spot potential issues early in the production cycle. Addressing them can protect patients and reduce manufacturer liability.
The new MDR and IVD regulations are causing apprehension within the industry not least because there is an increased strain on notified bodies who are not necessarily resourced to deal with the amount of queries and inspections they will have to handle.
Many are calling for an extension on the deadlines for transition. This may be wishful thinking due to the huge legal hurdles involved in making such a change.
But the advice coming out of the industry is for new developers to properly understand and research whether the device they are working on is likely to be in regulatory scope - and work quickly to develop a QMS that reflects the requirements of the MDR or IVDR.
For existing manufacturers with established devices on the market the advice is to start working with your notified bodies as early as possible to see what changes you need to out in place.
In some cases, as recertification will be necessary for all existing devices, it may be necessary to audit your entire portfolio and see what makes commercial sense to keep on the market.
The IVDR and MDR will likely impact on all medical device developers in one way or another. During this transition period, you should seek advice and support of notified bodies, trade organisations and consultants to ensure you will remain compliant when the new EU medical device regulations come fully into force.