Breaking Down EU MDR Implementation for Class 1 Medical Devices
Breaking Down EU MDR Implementation for Class 1 Medical Devices
Following the one-year delay in the MDR Date of Application, the 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 implementation from May 26, 2021:
- post-market surveillance (PMS),
- market surveillance,
- registration of economic operators,
- and registration of medical devices.
While this may seem overwhelming for Class I manufacturers, this article aims to shed light on some critical aspects of the European Union Medical Device Regulation implementation.
This article will provide clarity to many manufacturers about tackling the new challenges successfully.
Looking back to the Medical Device Directives (MDD)
After the deadline of May 26, 2021, 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 European Union Medical Device Regulation;
- Or, for manufacturers producing devices that have been up-classified, review by an NB in time.
Certain Class I products will still have three years to comply until May 26, 2024, providing welcome relief for eligible manufacturers.
Generally, under the new EU Medical Device Regulation implementation process, reusable surgical instruments and 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 allow manufacturers that choose to benefit from this extension period until they are Medical DR-compliant.
Under the new regulation, the manufacturer should note below points
- It is important to note that Class I manufacturers have no grandfathering provision.
- All products must be CE-marked and comply with the appropriate conformity assessment procedures.
- Non-sterile Class I products without a measuring function could obtain CE marking through self-certification under Annex VII.
- Class I products — sterile and/or with measuring functions — can also obtain CE certification through self-declaration; however, they require additional certification for the sterility aspects and/or measuring functions via an NB.
- Manufacturers of Class I devices can declare that their products are compliant by issuing the EU declaration of conformity and submitting the required technical documentation 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.
Because of the up-classification in the new regulations, it is critical for Class I manufacturers to first & foremost familiarize themselves with the latest classification rules.
So that they can find out
- Whether their devices fall under a new classification or not.
- And whether new conformity assessment routes are now applicable to their product range.
- Manufacturers 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 proper certification.
- To achieve compliance under the aegis of the new regulations, it is essential for Class I manufacturers not to 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 medical device has been up-classified to 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, up till now, only 13 NBs have been designated under the regulation. Therefore, manufacturers will be competing for their time and services to meet the deadline.
- Thus, manufacturers must start gathering the required, correct technical information to comply with 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, including updating their technical documentation by the end of the transition period.
Manufacturers must update detailed information about the medical device’s design, function, composition, use, claims, and clinical evaluation.
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 will typically perform detailed literature research to meet the defined requirements. Such a literature search will lead one to articles covering the medical device under evaluation or a competitor medical device.
More often than not, a device is part of a clinical study that needs to be performed on another medical device. Also, since the studies may often be quite old, it is mandatory to 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. The clinical evaluation report is still mandatory for CE Marking. That can drive companies to reconsider the “state of the art” for even Class 1 medical devices.
Step 3: Preparing for Post-Market Surveillance
Manufacturers must plan, establish, document, implement, maintain, and update a post-market surveillance (PMS) system, which must implement according to 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.
Manufacturers will use PMS to update risk-benefit, design, and clinical evaluation. For Class I medical device manufacturers, a formal PMS report needs to prepare.
In addition to a post-market clinical follow-up plan, higher classes of medical devices require a Periodic Safety Update Report.
PMCF is a proactive process designed to update the clinical evaluation constantly.
Thus manufacturers must ensure an ongoing review of their PMS and PMCF procedures. 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 Clinical Evaluation Report Writing as per EU MDR Implementation
As discussed earlier, the EU MDR does not allow for grandfathering of products. No complaint has been filed regardless of whether the medical device’s intended use and classification have been on the market for over 20 years.
A brand new application for CE marking needs to submit, 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 gathering the clinical evidence before the EU MDR implementation deadline.
Every Class I device that does not comply with the new requirements will need to be recalled. In such a case, Class Im.
However, no significant changes to the design and intended collection of the clinical evidence necessary to file the new technical documentation required by the regulation become impossible.
By complying early, manufacturers can use the existing post-market data. They can even 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 should be proportional to the risk class and type of medical device. Class I medical devices do not need a very complex 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. This can serve by implementing a certified standard such as ISO 13485:2016.
Our Summary Thoughts
Manufacturers must 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 cannot 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 Implementation 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 such a delay could cause.
We’re here to help!
Manufacturers who are feeling overloaded by the new requirements and unsure about the steps to take. They 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 is that the work to achieve compliance should start 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.
The Class I manufacturers can make the path toward compliance smoother, minimize risks, and prevent any impact on their bottom lines.
Contact us today to get our free ‘Buyer’s Guide to EU MDR Implementation Services’ Whitepaper!