Following the one-year delay in the MDR Date of Application, Class I medical devices, in the lowest risk class, must also conform to the new European Medical Device Regulation (EU MDR) to the end of their required performance lists. Despite any extension period, all devices, regardless of their class, must comply with the following requirements of the EU MDR from May 26, 2021: post-market surveillance (PMS), market surveillance, vigilance, registration of economic operators, and registration of devices.
While this may seem overwhelming for Class I manufacturers , through this article we aim to shed light on some of the key aspects of the EU MDR to provide clarity to manufacturers about tackling the new challenges successfully.
Looking back to the Medical Device Directive (MDD)
After the deadline of May 26, 2021, in order to keep trading on the EU market, all manufacturers will fall under one of the following obligations:
- Recertification under the MDD;
- Self-certification under the EU MDR;
- Or, for manufacturers producing devices that have been up-classified, review by a NB in time.
Certain Class I products will still have an additional three years to comply until May 26, 2024, providing welcome relief for eligible manufacturers. In particular, under the EU MDR, reusable surgical instruments and/or devices with a measuring function will be recategorized as Class Ir, Class I sterile devices as Im. However, no significant changes to the design and intended purpose of devices are allowed for manufacturers that choose to benefit from this extension period until they are MDR-compliant.
- No Grandfathering : Under the new regulation, it is important to note that there is no grandfathering provision for Class I manufacturers. Under the EU MDR all products must be CE marked and must comply with the appropriate conformity assessment procedures under the new regulation, in order to be placed on the market.
- Under the MDD, non-sterile Class I products, without a measuring function, could obtain CE marking through self-certification, in accordance with Annex VII. Class I products — sterile and/or with measuring functions — can also obtain CE certification through self-declaration; however, they do require additional certification for the sterility aspects and/or measuring functions via a NB.
- Manufacturers of Class I devices can declare that their products are compliant, by issuing the EU declaration of conformity and by submitting the required technical documentation as detailed in the regulation.
Step 1: Medical Device Reclassification and Notified Bodies
The new regulation now lists 22 rules for classification, compared with the previous 18. In view of the up-classification in the new regulations, it is critical for Class I manufacturers to first & foremost familiarize themselves with the newest classification rules, so that they can find out whether their devices fall under a new classification and if new conformity assessment routes are now applicable to their product range.
Manufacturers who are unaware of the change in classification for their product are at risk of not collecting and providing the correct post-market and clinical data to their respective Notified Bodies (NB) to achieve the correct certification. In order to achieve compliance under the aegis of the new regulations, it is important for Class I manufacturers to not underestimate the importance of acting quickly. without delay. Understanding the pivotal role that the NBs play in compliance, manufacturers should engage with their NB as quickly as possible, especially if a device has been up-classified so that they can meet the new regulatory requirements in time.
With a pre-existing shortage of NB capacity in Europe, manufacturers who are not prioritizing EU compliance may miss out on the required expertise they need to guide them through the new certification requirements. Also, as only 13 NBs have been designated under the regulation, manufacturers will be competing for their time and services to meet the deadline. Thus, it is imperative that manufacturers start gathering the required, correct technical information to achieve compliance under the new regulation. The old saying, “He who hesitates is lost,” is really in point here.
Step 2: Technical Documentation
All Class I devices, regardless of self-certification, still need to conform to all new regulation requirements, which include updating their technical documentation by the end of the transition period. Manufacturers must update detailed information about the design, function, composition, use, claims, and clinical evaluation of the medical device. Once the product satisfies the latest requirements, manufacturers must re-register it with the relevant, competent authority.
Since Class I devices do not require a clinical study, companies typically perform a detailed literature search to meet the defined requirements. Such a literature search will lead one to articles that cover the medical device under evaluation, or a competitor device. But the device is more often than not, part of a clinical study that was performed on another device. Also, since the studies may often be quite old, it is recommended to go through review articles first.
The complexity of conducting an extensive literature search and the fact that sometimes clinical studies are not available for the type of device under evaluation, can make the process of clinical evaluation a very tedious one. However, despite the possible unavailability of clinical studies, a clinical evaluation report is still required for CE Marking which is driving the need for companies to reconsider the “state of the art” for even Class 1 medical devices.
Step 3: Preparing for Post market Surveillance
Manufacturers are required to plan, establish, document, implement, maintain, and update a post-market surveillance (PMS) system, which should be integrated into the quality management system. The data from the PMS is key to identifying any need for vigilance reporting, updates to usability and the required technical documentation. PMS data should also be used to update risk-benefit, design, and clinical evaluation. For Class I device manufacturers, a formal PMS report needs to be prepared, in addition to a post-market clinical follow-up (PMCF) plan; higher classes of devices require a Periodic Safety Update Report (PSUR) as well. PMCF is a proactive process designed with the objective of constantly updating the clinical evaluation. Thus manufacturers must ensure an ongoing review of their PMS and PMCF procedures, such that this additional data and associated support can be smoothly and quickly provided through the device lifecycle.
Step 4: The Importance of Clinical Evidence in your CER Writing
As discussed earlier, the EU MDR does not allow for grandfathering of products, regardless of whether a device has been on the market for over 20 years and no complaint has been filed. A brand new application for CE marking must be submitted, providing clinical evidence to demonstrate the safety and effectiveness of the device. This means your Clinical Evaluation Report (CER) must be in order.
Manufacturers should not delay in gathering the clinical evidence before the EU MDR deadline (or after the extension period expires for eligible devices), every Class I device that does not comply with the new requirements will need to be recalled. In such a case, ces as Im. However, no significant changes to the design and intended purcollection of the clinical evidence necessary to file the new technical documentation required by the regulation becomes impossible. By complying early, manufacturers can use the existing post-market data or plan a post-market study to collect and submit clinical evidence with their technical documentation.
Step 5: Quality Management System
Since the EU MDR states that the Quality Management System (QMS) should be proportional to the risk class and type of device, Class I devices don’t need a very detailed system. However it must still meet the minimum requirements defined in Article 10(9).
Manufacturers must document, maintain, keep up to date, and improve aQMS, which could be served by implementing a certified standard such as ISO 13485:2016.
Our Summary Thoughts
It is absolutely critical for manufacturers to understand whether their device has been up-classified sooner rather than later, else they may risk not being able to engage their NB in time. If the already overworked NBs are not able to review a late submission from manufacturers, it may block the right to sell on the EU market. For more information, please reference our EU MDR resources for free whitepapers, templates and transition guides.
Potential cash-flow issues could result from a delay in product release, coupled with damage to reputation and loss of market share to competitors. Thus, a delay in compliance is not an option for Class I manufacturers, especially for smaller businesses, in light of the adverse bull-whip effect that such a delay could cause.
We’re here to help!
Manufacturers who are feeling overwhelmed by the new requirements, and unsure about the steps to take should seek help from experienced regulatory and compliance professionals. Through an actionable and tailored road map for implementation, we can help point businesses in the right direction and assist them throughout the transition period.
The key takeaway here is that the work towards achieving compliance should be started well in time to meet the appropriate deadline. By acting now, and seeking the help of experts to break down the new guidelines and requirements, Class I manufacturers can not only make the path toward compliance smoother, but also minimize risks and prevent any impact to their bottom lines.
Contact us today to get our free ‘Buyer’s Guide to PMS Services’ Whitepaper!