EU MDR 2017/745
Rule 1-4 – Non Invasive devices
Rule 5-8 – Invasive devices
Rule 9-13 – Active Devices
Rule 14-22 – Special Rules
The number of rules in the MDR has increased from 18 to 22, and additional changes have been made to existing rules, meaning many devices have new classifications. Manufacturers need to carefully review MDR Annex VIII to determine whether new classifications apply and subsequently if new conformity assessment routes are now applicable to their product range. For example, although re-usable surgical instruments are already Class I and currently do not require a notified body, they will fall under a new classification of Class I devices specifically for reusable surgical instruments known as Class Ir (But a recently published corrigendum has provided an extension of 4 years to such devices and these devices still remain in Class I – self declared if DoC is established until 24th May 2020), which requires notified body input to evaluate the cleaning, repackaging and reprocessing elements.
If a manufacturer’s device remains a Class I device under the MDR they may continue to self-certify, as long as MDR requirements are satisfactorily met. However, in order to achieve this, manufacturers will need to ensure their technical documentation is up to date in time for the MDR deadline. To do this they will need to self-declare the conformity of their devices with the requirements of the MDR and register relevant details on the EUDAMED database. The continued uncertainty surrounding Brexit also means that it would be preferable for manufacturers to ensure that they have an entity or Authorized Representative within the EU 27.
“It is fundamental that Class I manufacturers do not underestimate the required time and resources required to demonstrate total MDR compliance, especially as engaging with a no tified body may prove more complex than imagined. Notified bodies across Europe have undergone significant depletion (including at the time of publication LRQA, QS Zürich and UL), which in turn will cause a shortage of notified body capacity and regulatory expertise available to help manufacturers achieve full MDR compliance by the deadline.
Early compliance will enable manufacturers to either use already available post market clinical data or to perform a post-market study to submit as clinical evidence within the technical documentation required. As part of their quality management system, Class I manufacturers will now also be required to prepare a formal post market surveillance (PMS) report. This PMS report should result from a PMS procedure and documented plan, and must be a continuous proactive process with the objective of improving patient safety and also feeding into updating the clinical evidence.”
The MDR excludes all grandfathering of products, so even if a device has been on the market for more than 20 years, a new CE mark will now be required. After May 26, 2020, if Class I devices do not conform to new MDR requirements, then they will have to be taken off the market, impeding manufacturers’ ability to gather clinical evidence to file the new technical documentation under the requirements of the MDR.
There are now 22 rules in Annex VIII of the MDR. In both cases the rules are based on the potential risks associated with the device, technical design and manufacture of the device.
The correct product categorization and medical device classification is essential to make sure the appropriate legislation is applied. Therefore, the first step is to verify that a product qualifies for a medical device as opposed to a medicinal product or cosmetic product. The classification of medical devices is covered by Article 51 and Annex VIII of the ‘Proposed Regulation’. It is a risk-based approach that considers the intended purpose and the vulnerability of the human body by applying a set of criteria, like the degree of invasiveness, the duration of contact with the body and whether the medical device is active or not. Applying the 22 classification rules listed in Annex VIII allocates a medical device to one of the four different classes. It is considered more feasible, economically and justifiably, to categorize medical devices rather than all of them being subject to the rigorous conformity assessment procedures.
The Rules are as under:
Timely action needs to be taken to ensure that products remain on the EU market, maintaining cash flow, reputation and market share against competitors. Class I manufacturers should immediately turn their attention to EU MDR conformance and, in case of upward reclassification of their product into a higher risk class, that they have enough time to gather and source the required clinical evidence to achieve CE marking in time.
The MDR introduces new rules for products and devices that are not currently covered by the MDD or AIMDD. In particular, the MDR will apply to certain products without an intended medical purpose (listed in Annex XVI), which includes aesthetic or other implantable or invasive products such as non-corrective contact lenses, equipment for liposuction or hair removal lasers. The European Commission is empowered to add new groups of products to Annex XVI by means of delegated acts.
In addition, devices manufactured utilising non-viable human tissues or cells, currently exempted from the MDD and AIMDD (except human blood or plasma), will be considered medical devices. Moreover, the MDR specifically regulates devices incorporating or consisting of nanomaterial and introduces different classes in accordance with the level of exposure that they present. Manufacturers of these devices will be significantly affected as they do not have to comply with safety and performance requirements related to medical devices under the current regulatory framework.
The example of few such devices is mentioned below:
Derivatives of non-viable tissues and cells such collagen fillers (i.e. collagen extracted from tissues and cells) fall under the MDR.
Non-viable tissue and cell products such as demineralized bone matrix (i.e. bone from which inorganic minerals are removed), or acellular human tissues or tissue matrices, will not be covered by the MDR. They will continue to fall under the EUTCD (Directive 2004/23/EC on tissues and cells) and be regulated by the HTA.
Any device which includes, as an integral part, non-viable tissues or cells or their derivatives, and that has an additional function to that of the device will be assessed and authorized under the new MDR. In these cases, the provisions for donation, procurement and testing under the EUTCD will still apply to the incorporated tissues and cells.
In contrast, the MDR clarifies that products utilising viable biological materials or viable organisms such as bacteria or fungi are outside the scope of the medical devices framework.
According to MDR Article 2, the following products shall also fall under the definition of medical devices:
The MDR maintains the division of medical devices in four different classes (Class I, IIa, IIb and III). However, Annex VIII to the MDR introduces classification changes in relation to certain devices. For example, surgical meshes and spinal disc replacement implants or implantable devices coming into contact with the spinal column (except for screws, wedges, plates and instruments) will be up-classified to Class III. Similarly, all active implantable devices and their accessories will be considered as Class III.
The MDR provides that substance-based devices intended to be introduced into the human body via a body orifice or applied skin (Rule 21) may not be Class I. Consequently, substance-based devices currently in Class I will be up-classified and thus be subject to stricter requirements.
In addition, a new classification rule is likely to result in up-classification of several software products, which is expected to significantly affect the medical app industry. The majority of software currently falls under Class I. In contrast, the more stringent MDR requirements leave less room for the Class I classification. Changing from Class I to a higher class implies notified body involvement and conformity assessment procedures, which represents a heavier burden for software manufacturers in terms of budget and time planning.
Currently, borderline determinations are usually based on the consensus of the member states as reflected in guidance documents such as the Manual on borderline and classification. However, these documents are not legally binding nor do they ensure harmonized application across the EU.
Article 13(1)(d) of the MDD contains a mechanism to – partly – solve borderline questions at the EU level as it allows member states to request that the European Commission decide whether a specific product falls within the definition of a medical device. The first Commission implementing decision on this basis was taken on 8 August 2017 with respect to cranberry products, which were not considered to fall within the definition of a medical device.
Article 4 of the MDR strengthens the powers of the European Commission by allowing it to decide on these issues at its own initiative (after consultation of the relevant agencies) in order to ensure a more consistent classification of borderline products in the EU.
Importantly, some of the positions taken in the Borderline Manual may have to be reconsidered due to potential reclassifications brought by the MDR, which not only somewhat broadens the definition of a medical device (e.g. by considering the prediction and prognosis of a disease as a medical purpose) but also subjects some products without a medical purpose to the new rules (especially products for aesthetic purposes).
It is essential for us to assess – well in advance of the MDR application, i.e. 26 May 2020 – whether their devices are subject to reclassification or whether the products will fall under the extended scope of the MDR. Assessing the impact of potential changes and setting a strategic management plan will allow manufacturers to best tackle the transition to the new regime.
As can be expected, the greater the risk presented by the device, and the higher the classification, the greater is the required Notified Body involvement. In order to avoid costly changes and significant time-to-market delays for your product, it is best to discuss classification with your Notified Body as early as possible in the process.
To discuss classification or any aspect of CE Marking for your medical device with Maven’s team of experts, call us
We will work with you to classify your devices according to the MDR