Peter Rose, managing director Europe at Maetrics writes for Med-Tech Innovation News.
With the fast approaching end of the EU MDR transition period (May 26th, 2020) manufacturers need to ensure their products meet the new requirements by the deadline or risk restricted EU market access. The false assumption that industry changes caused by the EU MDR affect high risk devices could have calamitous repercussions for Class I manufacturers, particularly because the new classification requirements listed in the EU MDR affect all manufacturers, irrespective of current classification.
Key regulatory changes
The EU MDR was published in May 2017 at which point a three year transition period was triggered. The changes in regulation mean manufacturers have to ensure their products comply by the May 2020 transition period deadline. If a manufacturer chooses to re-certify under the MDD before May 2020, then they are automatically granted an extended transition period for compliance until the expiry of their certificate or May 2024, whichever comes first. However, Class I products are without a certificate and therefore cannot benefit from this extension and must meet the fast approaching 2020 deadline.
Class I manufacturers must ensure that all their Technical Information is updated and meets the EU MDR requirements (as well as ensure any required clinical evidence is up to date) and self-certify their products by May 2020. However, a major theme running through the EU MDR is the reclassification of devices, causing Class I manufacturers to find their products falling under a new and higher level of classification – at which point all Technical Information will need to be up to date and all appropriate clinical evidence will need to be compiled – all of which will then need to go through Notified Body review to achieve EU MDR certification by May 26th 2020.
Independent of the route chosen for EU MDR conformance it will be the responsibility of the manufacturer to guarantee compliance with the post-market requirements of the EU MDR (PMCF, PMS, PSUR, Vigilance reporting etc.) by the end of the transition period too. A specific noteworthy change involves the Quality Management System (QMS) for Class I manufacturers; previously Class I manufacturers did not require a formal QMS under the Medical Device Directive, only a few simple procedures fell under this requirement. The EU MDR however stipulates that all manufacturers (including Class I manufacturers) will require a QMS as stated in Article 10, paragraph 9 of the EU MDR – the easiest way to achieve this would be to implement ISO 13485:2016.
Under the requirements of the EU MDR, Class I manufacturers can self-declare the conformity of their products by issuing the EU declaration of conformity mentioned in Article 19 of the EU MDR (once the appropriate technical and quality documentation has been gathered). The difference for manufacturers is that under the MDD non-sterile Class I products that did not have a measuring function could self-certify for CE marking by confirming the product meets the essential requirements listed in the MDD Annex VII.
Re-classification
It is important for Class I manufacturers to fully understand the classification changes between the MDD and the EU MDR as well as to note that the number of classification rules has increased from 18 to 22 causing many (previously) Class I devices to be up-classified. For example, re-useable surgical instruments are already Class I and do not currently require a notified body, the EU MDR however lists a new level of classification for these devices (Class Ir) meaning that in order to be EU MDR certified these devices will now require notified body review of the cleaning, repackaging and reprocessing aspects.
In the EU MDR Annex VIII new classifications are listed detailing which classification conformity assessments are applicable to, therefore manufacturers should be scrutinising this section of the EU MDR to ensure they understand which components are relevant to their products. If notified body review is required, then it is necessary for manufacturers to engage as soon as possible to ensure certifications are issued in time for the EU MDR transition period deadline. If devices have been up-classified to Class IIa, IIb, Class III or a sub-section of Class I, then a notified body will be required
Early notified body engagement
Europe is currently witnessing a significant depletion in the number of notified bodies, with LRQA, QS Zürich and UL being the latest three to withdraw from medical device regulation, causing an issue of capacity across the medical device industry. To add to the strain, only two notified bodies have been designated to date under the EU MDR creating an over-demand for their services. If Class I manufacturers now have a device which needs notified body review, it is vital that they engage with their notified body right away to guarantee they have the capacity to assist, review the technical documentation and issue a CE certificate by the May 26th, 2020 deadline.
Self-certify under the EU MDR
If a manufacturer’s device does not fall under the new classification rules, then they can continue to self-certify their devices, meeting the EU MDR requirements. To ensure best practice and on-time certification, the product’s technical documentation needs to be kept up to date, manufacturers will need to self-declare the conformity of their devices in line with the EU MDR and register the required data on the EUDAMED database, all before May 2020.
Clinical evidence
The EU MDR does not allow the grandfathering of products; irrespective of whether a device has been on the market for over 20 years, a new CE Mark will be required in order for manufacturers to keep trading. The importance for manufacturers to start gathering clinical evidence as soon as possible can not be stressed enough, as it is a sure-fire way to successfully meet the fast approaching EU MDR deadline. Once the May 2020 deadline has passed, and a manufacturer’s product does not meet the requirements of the EU MDR, then they will no longer be able to trade on the market, restricting access to gather the clinical data required for the technical file to be EU MDR compliant. Complying now means manufacturers can either use already available post market clinical data or perform a post-market study to submit as clinical evidence within the technical documentation.
It is clear the time to act for Class I medical device manufacturers is now. Any delay in starting EU MDR conformance preparation increases the risk that a device may have been up-classified without the manufacturer knowing, and then manufacturers risk being turned away from over-capacity notified bodies which are unable to review their technical documentation in time for the deadline. Not only will the manufacturer be stopped from trading their products on the EU market post May 26th 2020, but the fall-out will have a knock-on effect on their cash-flow and market reputation, potentially resulting in loss of market share to savvy competitors.
