The medical device needs to have a CE mark before it may be sold in the European Economic Area (EEA). The European General Medical Devices Directive's "essential requirements" are met by the medical device according to the CE mark. Furthermore, it demonstrates that medical equipment can be freely marketed within the EEA without any further restrictions. Even if the medical device was produced outside of the EEA, CE marking is required. The CE mark must be acquired and applied to the product by the manufacturer alone. This obligation belongs to the importer within the community if the goods are brought in from outside the EEA. So, here are some steps that help to achieve the CE mark for medical devices.
Start with the classification and choosing the Conformity Assessment Route: The manufacturer of medical equipment must comply with one of four conformity assessment processes to receive a CE mark. The specific procedure will rely on the medical device's classification. Class I, Class II-a, Class II-b, or Class III are possible classifications for medical devices.
Devices are often grouped based on the risks that are believed to be present. It is taken into account several things, such as how long the device is meant to be used continuously, whether it is intrusive, and whether it contains any pharmaceuticals. The restrictions imposed on the device through the conformity assessment technique are tighter the more perceived associated risks linked with the device are believed to be. Every producer is required to categorize their medical device and choose the proper Conformity Assessment Procedure. For that, the CE mark consultant provides accurate information and supports in obtaining the CE mark for medical devices.
Making for the assessment procedure: The manufacturer is expected to deliver a technical file for all categories of devices. The conformity assessment procedure chosen will determine the requirements for the technical file. The documentation should typically go into the product's design, production process, and intended use. In the end, the maker must offer sufficient proof that the product complies with all applicable Medical Devices Directive standards.
Conformity Assessment ways: The manufacturer of Class I (low-risk) devices may voluntarily certify that the product complies with the Directive's fundamental standards. A Notified Body must also receive an application from manufacturers of sterile goods and of devices with a measuring function for certification of the manufacturing processes related to sterility or metrology. The maker must register with the Competent Authority after determining that their product satisfies all pertinent essential requirements.
Class II-a device manufacturers must also certify their products' compliance with the Directive. However, a conformity assessment to be carried out by a Notified Body is also required to support this statement (an independent entity that has been designated by the national regulatory body). The following four conformity assessments are available for manufacturers to select from:
- an inspection and testing of each product
- an audit of the manufacturing quality assurance system;
- an audit of the final inspection and testing
- an audit of the full quality assurance system.
If the device is a Class II-b device, a Notified Body is required to conduct an "Annex III examination" in addition to one of the assessments 1, 2, or 3 that are mandatory for Class II-a devices. The Notified Body determines whether or not a representative sample of the device manufacturer complies with the Directive using the Annex III examination procedure.
Similar to Class II-b devices, Class III devices must go through an evaluation process. However, the manufacturer must also submit a design document for review if they decide to have Notified Body audit the entire quality assurance system. The manufacturer may also choose to have an Annex III assessment, although this option is only compatible with assessments 1 or 2 (above), which are available for Class II-a devices.
Final steps to CE mark: Manufacturers of Class II-a, Class II-b, and Class III devices need to wait for the Notified Body to provide a certificate. Once the required assessment has been completed (and the certificate, if applicable), the manufacturer may apply the CE mark on their medical equipment and place it on the market. The CE mark must be visible, readable, and indelible. If a Notified Body was used in the assessment method, the Notified Body's number must be shown beside the CE mark.
Source: https://cemarkprocedures.wordpress.com/2022/11/28/steps-for-getting-your-medical-device-ce-marked-with-eu-mdr-requirements/
