Note:Note: On April 17, 2020, the European Parliament adopted the Commission proposal to postpone the Medical Devices Regulation until May 26, 2021, due to COVID-19. This article has been updated since publication to reflect that decision.
Although Class I medical devices are the lowest risk of classification, Class I manufacturers should not shunt complying to the new European Medical Device Regulation (EU MDR) to the end of their to-do lists. Following the one-year delay to the MDR Date of Application, the new deadline for compliance is now May 26, 2021, and this will come around remarkably quickly; however, certain Class I products will still have an additional three years to comply, providing welcome relief for eligible manufacturers.1 Specifically, devices that are either reusable surgical instruments, Class I sterile products, or Class I devices with a measuring function have until May 26, 2024, to comply following the second corrigendum published on November 25 and formally adopted on December 17, 2019.
The first step for Class I manufacturers is to familiarize themselves with the EU MDR classification rules, especially as many Class I devices have been up-classified in the new regulation. Uninformed manufacturers who are unaware that their products’ classification has changed, risk not having the correct post-market and clinical data to provide to their notified bodies (NB) to achieve the correct certification. In light of the new changes and to achieve compliance, a large number of manufacturers will need to seek NB review and sign-off for their devices.
This may sound overwhelming for Class I manufacturers; however, the steps below are aimed at clarifying some of the key aspects of the EU MDR to provide clarity to manufacturers about tackling the new challenges successfully.
Step 1: A Look Back to the Medical Device Directive (MDD)
Following publication of the EU MDR in 2017, a three-year transition period (now four due to the deadline delay) started for manufacturers to shift over from the MDD to the EU MDR. Once the May 26, 2021, deadline hits, 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 an NB in time.
The corrigendum published on November 25, 2019, alters Article 120(3) of the EU MDR. This enables a three-year delay in implementation specifically for devices that fall into the Class I category under MDD and will be recategorized as Class Ir (re-useable surgical instruments) and/or Ir (have a measuring function) and/or Im (supplied as a sterile device) under the EU MDR. This only applies if their existing declaration of conformity under MDD was made before May 26, 2021. Manufacturers that choose to benefit from this extension period cannot, however, make any significant changes to the design and intended purpose of their devices until they are MDR-compliant. Further guidance regarding "significant changes" may be found in MDCG 2020-3.2
Moreover, irrespective of any extension period, all devices of all classes must comply with the following requirements of the EU MDR from May 26, 2021: postmarket surveillance, market surveillance, vigilance, registration of economic operators, and registration of devices. In relation to the latter two elements, the launch of the European database on medical devices (EUDAMED) has now been delayed until May 2022 though the requirements for recording data still apply.
For Class I manufacturers, it is important to note that under the new regulation there is no provision for grandfathering and all products must be CE marked under the EU MDR and will be subject to the appropriate conformity assessment procedures under the new regulation to be placed on the market.
Under the MDD, nonsterile Class I products, without a measuring function, can 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 an NB.
Now — under the EU MDR — it is still possible for manufacturers of Class I devices to declare that their products are compliant, by issuing the EU declaration of conformity referred to in Article 19 and after drawing up the technical documentation set out in Annexes II and III.
Step 2: Reclassification and Notified Bodies
One of the main changes outlined in the EU MDR is the addition of new classification rules — 22 rules are now listed in the new regulation compared with the previous 18, with many devices being up-classified.
For this reason, it is critical for Class I manufacturers to carefully examine all the new EU MDR classification rules in Annex VIII to find out whether their devices fall under a new classification and if new conformity assessment routes are now applicable to their product range. If a device has been up-classified, manufacturers must engage with their NB at once and define the process that needs to take place to implement the change and meet the new regulatory requirements in time.
NBs play a pivotal role in EU MDR compliance, and it is important for Class I manufacturers to not underestimate the importance of acting quickly and not delaying. With Europe experiencing a shortage of NB capacity, manufacturers who aren’t prioritizing EU MDR compliance risk missing out on access to the required expertise needed to assist them with the new certification requirements.
Moreover, to date only 13 NBs have been designated under the EU MDR; this means that these NBs will face an enormous amount of work coming from manufacturers, who will be competing for their services to meet the EU MDR deadline.3 It is for this reason that manufacturers should not delay and start gathering the right technical information for their devices to obtain CE marking under the new regulation.
Step 3: Technical Documentation
Self-certification doesn’t mean no documentation. Even if a manufacturer’s product remains a Class I device, and self-certification is allowed under the EU MDR, devices will still need to conform to all new regulation requirements.
For this reason, manufacturers need to be prepared to update their technical documentation by the end of the transition period, including detailed information about the design, function, composition, use, claims, and clinical evaluation of the medical device. Once the device meets the EU MDR requirements, manufacturers will need to re-register their product with the relevant competent authority where the legal manufacturer is based as well as decide which address will go on the product packaging or labeling.
Step 4: Preparing for Postmarket Surveillance
The new EU MDR also requires manufacturers to plan, establish, document, implement, maintain, and update a post-market surveillance (PMS) system, and this needs to be integrated into the quality management system. PMS data is crucial to identify any need for vigilance reporting, updates to usability and the technical documentation and should be used to update risk-benefit, design, and clinical evaluation.
For higher classes of devices, manufacturers are required to prepare the Periodic Safety Update Report; however, a formal PMS report needs to be prepared solely for Class I manufacturers.
Together with the PMS report, manufacturers also need to put in place a post-market clinical follow-up (PMCF) plan. A PMCF is a proactive process aimed at constantly updating the clinical evaluation. Therefore, it is the manufacturer’s responsibility to ensure ongoing review of their procedures for PMS and PMCF, as well as establishing the responsibility necessary to ensure the provision of this additional data and associated support.
Step 5: The Importance of Clinical Evidence
It doesn’t matter if a device has been on the market for over 20 years and no complaint has been filed, there is no grandfathering of products under the EU MDR. Manufacturers need to submit a brand-new application for CE marking, providing clinical evidence to demonstrate the safety and effectiveness of their device.
Delaying in gathering clinical evidence is a risky mistake; after the EU MDR deadline (or after the extension period expires for eligible devices), every Class I device that does not conform to the new requirements will need to be removed from the market. If this happens, manufacturers will not be able to collect the clinical evidence necessary to file the new technical documentation required by the regulation. Early compliance enables manufacturers to use the already available post-market data or put together a postmarket study to submit as clinical evidence within their technical documentation.
Step 6: Quality Management System
The list of EU MDR requirements is not over. On top of all that is mentioned above, the new regulation also requires manufacturers to document, maintain, keep up to date, and improve a quality management system (QMS). Although it is not specified in the EU MDR that the QMS needs to be certified, this requirement is best served by implementing ISO 13485:2016.
Class I manufacturers don’t necessarily need to put in place an extra detailed system as the EU MDR establishes that the QMS should be proportionate to the risk class and the type of device; however, it must still meet the minimum requirements that are set out in article 10 (9).
Step 7: Why Now?
Manufacturers need to know whether their devices have been up-classified sooner rather than later; Class I manufacturers who are unaware whether their products have been reclassified risk not being able to engage their NB in time. Overworked NBs might not be able to review late manufacturers’ technical documentation, blocking their right to sell on the EU market.
Such a chain of events could bring potential cash-flow problems due to the delay in releasing the product, together with reputational damage, and loss of market share to competitors. Delaying in complying should not be considered an option for Class I manufacturers, especially for smaller businesses, in light of the deep repercussions that a delay could bring.
Step 8: Don’t Be Afraid to Ask for Help
For manufacturers feeling overwhelmed by the new requirements and who are unsure about what steps to take toward the EU MDR should seek help from experienced compliance professionals. Third-party service providers can point businesses in the right direction and assist them throughout the transition period. Through an actionable and tailored roadmap for implementation, compliance experts can help in delivering a successful plan of action.
Class I manufacturers need to make sure that they work toward compliance in time for the appropriate deadline. The help of guidelines and experts can make the path toward compliance smoother, but Class I manufacturers need to act now to minimize the risks and prevent impacting their bottom lines.
- "Parliament decides to postpone new requirements for medical devices," European Parliament News, April 4, 2020.
- MDCG 2020-3, "Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD," Medical Device Coordination Group Document, March 2020.
- Euopean Commission, Notified Bodies.
This article was written by Peter Rose, Managing Director Europe for Maetrics, Nottingham, UK. The company is headquartered in Indianapolis, IN. For more information, visit here .