The EU MDR is shaking up the medical device industry and classification rules have not been left untouched. In spite of this, a critical misunderstanding threatens Class I device manufacturers: As the end of the Medical Device Regulation’s (MDR) transition period, set for May 26, 2020, steadily beckons, there is a mistaken belief that that the need to comply with the EU MDR only applies to businesses manufacturing higher risk devices. In reality, Class I manufacturers are under just as much pressure as their peers who are making products in higher classes and should be acting swiftly to ensure that they confirm compliance with the new regulation or risk losing the ability to continue to sell their products in the EU.
Specifically, Class I manufacturers should be aware that following publication of the EU MDR in 2017 a three-year transition period commenced, at which point all manufacturers of medical devices automatically fell under one of three obligations to continue trading their products on the EU market:
- For products recertified under the MDD (before May 25, 2020), manufacturers may take advantage of the extended transition period stretching up to May 2024. This, however, does not apply to Class I products, as they have no certificate and will have to be comply with the MDR much earlier (by May 26, 2020) and will be unable to benefit from the extended transition period
- Class I manufacturers may update all technical Information in line with the MDR, including clinical evidence and self-certify Class I products (only) by May 26, 2020
- They can update all technical Information in line with the MDR, including clinical evidence and have a notified body review for compliance all by May 26, 2020 (includes Class I products that have been up-classified)
Irrespective of the route selected, all manufacturers must comply with the post-market provisions of the MDR (including PMCF, PMS, PSUR, Vigilance etc.) from May 26, 2020. Class I manufacturers previously did not require a formal quality management system (QMS) under MDD, but simply had to comply with a few simple procedures. The MDD contained several Annexes that provided a roadmap for conformity to the provisions. For example, non-sterile Class I products without a measuring function could obtain CE-marking through self-certification in accordance with MDD Annex VII confirming the product meets the essential requirements.
Beginning May 26, 2020, however, all manufacturers, including Class I manufacturers, will require a formal QMS as per Article 10, paragraph 9 of the MDR. The latter is best achieved by implementing EN ISO 13485:2016. In addition, under the EU MDR manufacturers of Class I devices can still declare the conformity of their products by issuing the EU declaration of conformity referred to in MDR Article 19 after drawing up the appropriate technical and quality documentation.
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, which requires notified body input to evaluate the cleaning, repackaging and reprocessing elements.
If the devices in question are no longer Class I but have been up-classified to Class IIa, IIb or even Class III or they have been up-classified into a subsection of Class I, then they will also need to engage a notified body to ensure that timelines are met for implementing change.
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 notified 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.
To date, only two notified bodies have currently been designated under the EU MDR with the expectation that this should reach a total of 16–20 by the end of 2019. Clearly, however, this depletion has already created, and will continue to cause, a pressing overdemand for their services. In this light it is evident that Class I manufacturers that have a device which needs notified body review, should engage with their notified body right away to guarantee they secure their capacity to assist, review the technical documentation and issue a CE certificate by the looming May 26, 2020 deadline.
In addition to this, 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. 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.
Class I manufacturers need to immediately tackle the issue of up-classification and understand if this pertains to their device. If so, speedy intervention to ensure that a notified body is able to review their technical documentation is required, especially given the dearth of available notified bodies and their capacity concerns. 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.