Classification in EU MDR

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.

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.

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.

REVISED BORDERLINE DETERMINATION MECHANISM

REVISED BORDERLINE DETERMINATION MECHANISM

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

·     Our team specializes in medical device regulatory consulting and can help you determine the proper classification for your medical device or IVD. We can assist with classification to the MDD, AIMDD, IVDD, or the MDR and IVDR.

·     Our in-depth knowledge of European medical device regulations ensures that we can assist you in finding the most efficient regulatory approval strategy for your device. We are also gaining significant experience with the MDR.

·     We can assist you in preparing a Technical File or a Design Dossier that demonstrates compliance with the MDD, IVDD, or AIMDD as well as the MDR and IVDR.

Content Credits @Dolly Sharma