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Class 1 Medical Device Overview
Medical devices classified under MDR Class 1 are considered to be low-risk devices. These devices do not support or sustain life, and they pose minimal risk to patients or users. Manufacturers of Class 1 medical device can self-declare compliance with MDR and affix the CE Mark without requiring certification from a notified body.
Class 1 medical device often non-invasive, meaning they do not enter the body, or if they do, they do so in a limited manner. These include non-invasive devices, such as bandages, wheelchairs, stethoscopes, and surgical instruments like scalpels. These devices do not pose significant harm to the patient or user if used as intended. They are often used externally or in non-critical applications.
We have experts with previous experience in Class 1 medical device EU MDR compliance for fast CE Logo affixing on device and EU market entry. Our professionals know specific requirements for Class 1 under the Medical Device Regulation.
Class 1 Medical Device Conformity Assessment
Class 1 medical device manufacturers can self-certify their CE Marking compliance with MDR without the need for a Notified Body to market in the EU. However, this applies only to Class 1 devices without a measuring function or that are non-sterile i.e. Class 1s and Class 1r respectively.
- Manufacturers must implement a Quality Management System that aligns with MDR requirements is a must in this case.
- Manufacturers are required to maintain technical documentation for their devices. This includes a description of the device, intended use, design and manufacturing processes, risk management, and clinical evaluation with supporting biological, electrical, software and performance test results.
- All Class 1 medical device manufacturers must conduct a clinical evaluation to demonstrate the device’s safety and performance. This involves gathering and analyzing clinical data, which includes literature reviews, pre-clinical studies, and post-market surveillance data and completing a clinical evaluation report.
- Manufacturers are required to establish a PMS plan to monitor the performance of the device once it is on the market.
- Labels on Class 1 medical device must include the manufacturer’s name and address, a description of the device, and any warnings or precautions.
- Class 1 medical devices are required to have a UDI, which helps in tracking and identifying medical devices through their distribution and use
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Class 1 Medical Device Consultants
We have experts with previous experience in Class 1 medical device EU MDR compliance for fast CE Logo affixing on device and EU market entry. Our professionals know specific requirements for Class 1 under the Medical Device Regulation. Our expertise ensures that the necessary documentation in line with regulatory expectations. Without such expertise, manufacturers may face significant challenges in and delays in market and at the port of EU entry.
- Guidance and Technical File preparation
- Identifies test requirements and reviews the external reports
- Biological evaluation
- Risk analysis
- Prepare Clinical Evaluation report as per Meddev 2.7/1 Rev 4.
- Arranges Notified Body and coordinates with them till the issue of CE Certificate
- Arranges EU Representative and complete EUDAMED registration
- Arranges Free Sale Certificate from the European Union
How to build a Class 1 Medical Device Technical Documentation as per MDR 2017/745? We have the answer and the right team to do it for you.
Steps for placing Class 1 Medical Device in Europe
Manufactures must make sure the following before exporting medical devices to Europe or start marketing in Europe.
- Confirm product as a medical device.
- Confirm product as a Class Is or Im or Ir medical device.
- Confirm if the general safety and performance requirements have been met.
- Perform clinical evaluation.
- Prepare technical documentation.
- Request notified body involvement (For Class 1s, 1m & 1r)
- Prepare instruction for use and labeling.
- Check compliance with general obligations for manufacturers as established in Article 10
- The draw of the EU Declaration of Conformity
- Affix the CE marking.
Steps after placing Class 1 Medical Device in EU
Manufactures must maintain strict vigil on the quality and performance of their products after start of sale. The following are important to monitor.
- Collect and evaluate Post Market Surveillance Data
- Vigilance system
- Non-conforming products -If a manufacturer finds that a device which they have placed on the market or put into service is not in conformity with the EU MDR, they will immediately take the necessary corrective action to bring that device into conformity, to withdraw it or to recall it, as appropriate.
MDR Process - Class 1 Self Declaration
Frequently Asked Questions
What happens if the device classification changes?
- If a device is reclassified to a higher class, the manufacturer can no longer self-declare conformity. Instead, a Notified Body must be involved in the conformity assessment process.
- If a device is modified by changing intended use to a higher class, the manufacturer must apply with a Notified Body and conformity assessment process should be followed for the CE Certification.
Do Class 1 medical devices need to be registered with the Competent Authorities?
Yes, manufacturers of Class 1 devices must register their devices in the European Databank on Medical Devices (EUDAMED). the final date for compulsory registration not provided.
How do I affix the CE mark on a Class 1 device?
Once the device meets all relevant requirements of the MDR, the manufacturer can affix the CE mark logo on the device and its packaging. The CE mark must be placed visibly, legibly, and indelibly on the device or its packaging.
What are the obligations of the manufacturer under self-declaration?
The manufacturer must ensure ongoing compliance with the MDR, including maintaining the current and updated version of technical documentation, covering PMS, serious incidents, clinical evaluation report to Competent Authorities in case of an investigation.
Do I need a Quality Management System (QMS) for a Class 1 device?
The European Union’s Medical Device Regulation (MDR) requires manufacturers of all medical devices, including Class 1 devices, to develop a Quality Management System (QMS) and implement for the scope carried out by the organization.