· Medical device CE certification- -MDR certification process
Step 1: Determine the regulations and coordination standards that the product meets
Determine the regulations and coordination standards that the product meets, and understand the certification process. The detailed technical document used by the EU coordination standards to guide the product to meet the basic requirements of the directive.
Step 2: Classify the products
Medical device products are classified according to the regulatory requirements of MDR, and 22 rules are specified in Appendix VIII of regulation MDR 2017/745. According to the danger degree of medical products, the products are divided into class I, Class IIa, Class IIb, and Class III.
In our actual work, the products will be subdivided into Class I, Class I *, Class Ⅱa, Class Ⅱb, Class Ⅱb implant and Class III. Class I * includes (Class I sterilization, Class I measurement, and Class I reusable surgical instruments).
According to different certification processes, Class I products do not require the participation of notified bodies, make a declaration of conformity DOC and obtain a certificate of registration by an authorized representative of the EU in the competent authorities of the corresponding EU member states.
Products above Class I, that is, class I *, Class II a, Class II b, Class II b implant and Class III products, require the participation of the notified body, review and issue ISO13485 certificates and CE certificates.
Step 3: Establish and run ISO13485 quality management system
A quality management system shall be established in accordance with the requirements of the EU medical device regulations, based on ENISO13485:2016/AC, and meet the other requirements specified by the MDR; Class I products by the enterprise self-declaration, and establish a quality management system, no need to announce the audit, but recommend Class I product manufacturers to ISO13485 certification; Products above Class I, i.e., Class I *, Class II a, Class II b, Class II b Implant and Class III products, must be reviewed for compliance and issued a certificate by a notified body with MDR qualification.
Step 4: Carry out product testing and obtain test report
Determine all the testing standards of the product in the EU, and determine the testing qualification of the testing organization during testing. If the products need to be audited by the notified body, the notified body shall determine whether the certificate issued by the testing body is recognized. The product shall pass the test and obtain a qualified test report.
Step 5: Write MDR technical documentation
Manufacturers must prepare MDR technical documentation and obtain an EU authorized representative agreement according to the regulatory requirements and harmonized standard requirements that the product complies with. MDR technical document requirements, please check the second phase, The MDR technical documentation for products above Class I, i.e., Class I*, Class IIa, Class IIb, Class IIb implanted and Class III products, need to be audited by the notified body, and the MDR CE certificate is obtained after the audit is passed.
Step 6: Complete the CE declaration of conformity(DOC) and attach the CE mark
After completing the CE Declaration of conformity DOC, the manufacturer needs to sign and seal the declaration of conformity. Then paste the CE mark on the product, and the CE mark must be clearly affixed to the product or its nameplate in accordance with its standard pattern. The CE mark of a product issued by a notified body must bear the notice number of the notified body.
Step 7: Carry out post-listing supervision, tracking and maintenance
· Technical documentation requirements for medical device MDR certification
Technical documentation is a very important matter in the EU medical device regulations, its purpose is to require companies to prepare sufficient technical information and proof for the notified body to review, the competent authorities to access, or customers need to be issued. The requirements of each EU directive for "technical documentation" are different, here only take the requirements of "medical devices" commonly used by Chinese exporters as an example to explain.
Medical device Regulation 2017/745 requires "technical documentation" to include: company profile and the name and contact information of the EU authorized representative; CE Declaration of conformity (or self-assurance declaration, if the product is used in conjunction with other equipment, there should be certification materials that meet the basic requirements as a whole), the main contents of the technical document are as follows:
1. Device description and performance indicators, including variants and accessories
1.1. Device description and performance indicators
(a) A general description of the product or trade name and device, including its intended use and intended user;
(b) the basic UDI-DI attributed by the manufacturer to the device in question as described in Part C of Appendix VI, provided that the identification of the device is based on the UDI system or is clearly identified by a product code, catalog number or other traceable explicit reference number;
(c) the intended patient population and medical conditions to be diagnosed, treated and/or monitored, as well as other considerations such as patient selection criteria, indications, contraindications, vigilance;
(d) the principle of the operation of the device and its scientifically proven mode of operation (if necessary);
(e) the qualification grounds of the device product;
(f) the risk level of the device and the rationale for the classification rules applied in accordance with Appendix VIII;
(g) A description of any novel features;
(h) A description of device accessories, other devices and other non-device products used in conjunction with them;
(i) A description or complete list of the various device configurations/variants to be marketed;
(j) A general description of the critical functional element, such as its parts/assemblies (including software, where applicable), its formation, composition, function, and related qualitative and quantitative composition. Where appropriate, include marked graphical representations (such as diagrams, photographs and drawings) clearly indicating key components/assemblies, including adequate instructions for understanding drawings and diagrams;
(k) Descriptions of (original) materials incorporated into key functional elements and in direct or indirect contact with the human body, such as during extracorporeal circulation of body fluids;
(l) The technical specification (features, dimensions and performance attributes) of the device and any variants/configurations and accessories thereof, normally appearing in the product specification available to the user (e.g. in brochures, catalogues and similar publications).
1.2. Refer to previous generations of similar products
(a) A summary of the previous generation of devices produced by the manufacturer, if any;
(b) An overview of similar devices found on the EU or international market, if any.
2. Information to be supplied by the manufacturer
2.1. Labels on the device and its packaging (stand-alone packaging, sales packaging, transport packaging under certain regulatory conditions) (in a language acceptable in the Member State in which the device is intended to be sold);
2.2. Instructions for use (in a language acceptable in the Member State in which the device is intended to be sold);
3. Design and manufacturing information
3.1. Information used to understand the device design phase;
3.2. Complete information and specifications, including the manufacturing process and its validation, its adjuvants, continuous monitoring and product testing. Complete data should be included in the technical documentation;
3.3. Identify all venues for design and manufacturing activities, including suppliers and subcontractors.
4. General safety and performance requirements
The documentation shall contain information demonstrating compliance with the general safety and performance requirements provided in Appendix I, which are applicable to the device and take into account its intended use, and include justification, confirmation, and validation of these protocols for meeting those requirements.
5. Risk benefit analysis and risk management
6. Product verification and confirmation
The documentation shall contain the results and critical analysis of all validation and validation tests and/or studies performed to demonstrate that the device complies with the requirements of this Regulation, in particular to demonstrate that it complies with applicable general safety and performance requirements.
6.1. Preclinical and clinical data
6.1.1. Test results, such as engineering, laboratory, simulated use and animal testing, and evaluation of the published literature applicable to the device, taking into account its intended use or devices substantially similar to the preclinical safety of the device and its conformance to specifications;
6.1.2. Detailed information on the test design, the complete test or study protocol, the method of data analysis, in addition to the data summary and the test conclusions, in particular with respect to:
(a) Device biocompatibility, including identification of all materials in direct or indirect contact with the patient or user;
(b) Physical, chemical and microbial characterization;
(c) Electrical safety and electromagnetic compatibility;
(d) Software validation (describing the software design and development process and software validation certificates used in the finished device). This information typically includes summary results of all confirmations, validations, and tests performed internally and in simulated or real user environments prior to release. It shall also cover all different hardware configurations and, where applicable, the operating system identified in the information provided by the manufacturer);
(e) Stability, including product expiration date;
(f) Performance and safety.
6.1.3. Clinical evaluation report and its updated version and clinical evaluation plan;
6.1.4. The PMCF Plan and the PMCF evaluation Report or any justification for why PMCF is not applicable.
6.2. Additional information
(a) Additional information on medicated devices
(b) Accessory information on allogeneic or animal-derived devices
(c) Additional information on a device consisting of a substance or combination of substances intended to be introduced into the body and absorbed by the body or locally diffused into the body.
(d) Additional information on devices containing CMR or endocrine substances.
(e) A description of the environmental conditions of the relevant manufacturing steps for devices placed on the market under sterile or defined microbial conditions. For devices placed on the market under sterile conditions, a description of the method used, including a confirmation report on packaging, disinfection and aseptic maintenance. The confirmation report shall include the biological load test, pyrogen test and disinfectant residue test (if applicable).
(f) A description of the methods used to ensure the accuracy of the specification for devices placed on the market with determination functions.
(g) If the device is to be connected to another device in order to operate as intended, the description of the combination/configuration shall include a certification that the device meets the general safety and performance requirements when connected to any such device conforming to the characteristics specified by the manufacturer.
7. Post-market surveillance
7.1 PMS for post-market surveillance
7.2 Post-market surveillance report
7.3 Periodic Security Update report PSUR
8. Eu Authorized representative information and authorization letter
9. Declaration of conformity document
10. CE conformity mark
· Label requirements for CE certification of medical devices
(a) Device name or trade name.
(b) the details necessary for the user to identify the device, the contents of the package, and the intended use of the device that is not apparent to the user.
(c) the name, registered trade name or registered trademark of the manufacturer and the address of its registered place of business.
(d) the name of the authorised representative and the address of the authorised representative's registered place of business (if the manufacturer has its registered place of business outside the EU).
(e) If applicable, indicate that the equipment contains or includes:
- Drugs, including human blood or plasma derivatives or
- Tissues or cells of human origin or derivatives thereof or
- Tissues or cells of animal origin or their derivatives
(f) If applicable, the labelling information shall comply with the requirements for "labelling" in the MDR.
(g) The batch number or serial number of the equipment is preceded by "batch number", "serial number" or equivalent symbol (as the case may be).
(h) UDI.
(i) A clear indication of the time limit for the safe use or implantation of the device, expressed at least by the year and month to which it relates.
(j) Specify the date of manufacture if no deadline for safe use is specified. If the date is legible, the date of manufacture can be used as part of the batch or serial number.
(k) Specify any special storage and/or transport conditions applicable.
(l) If the device is provided in a sterile manner, its sterile status and method of sterilization shall also be indicated.
(m) Warnings or precautions that require the immediate attention of the user of the device and any other person. This information can be kept to a minimum, in which case more detailed information will appear in the instructions for use and will need to take into account the intended user.
(n) If the device is intended for single use, specify accordingly. Manufacturers' single-use symbols should be consistent throughout the EU.
(o) If the device is a single-use device that has been reprocessed, provide an indication of that fact, the number of reprocessing cycles that have been performed and any limits on the number of reprocessing cycles.
(p) If the device is custom made, provide the term "custom device".
(q) An indication that the device is a medical device. If the device is intended for clinical research use only, it should be marked "clinical research use only".
(r) If the device contains a substance or combination of substances intended to be introduced into the body or applied to the skin through the orifice of the body and absorbed by the body or locally sprayed on the body, provide quantitative information about the overall quantitative composition of the device and the principal component responsible for achieving the principal intended effect.
(s) Provide serial numbers for active implantable devices and serial numbers or lot numbers for other implantable devices.
