CE certification of medical devices
CE certification of medical devices
The single European market is one of the most advanced markets for distribution of medical devices. This article is dedicated to the procedure of issuance of licenses and certificates for unlimited trade of the devices manufactured outside the EU countries.
What are the CE certificate and the CE marking of the medical device
Translated from French, the abbreviation CE means “European conformity” – conformité européenne. The СЕ marking (or the CE claim) is a mark that denotes that the medical device complies with the regulation requirements of the European Union. The regulation requirements are specified in the following European standing orders:
The medical devices that do not comply with these requirements cannot be imported to the European Union and allowed for trade on the territory of the European Union.
The following documents can confirm the compliance with the regulation requirements:
The Declaration of Conformity for the I class medical devices (the non-sterile ones and the ones that have no measuring function) should be made legal by the manufacturer itself (self-declaration).
The other devices require getting the CE certificate with the help of a notified body of the European Union for legal trade on the territory of the European Union.
The CE certificate contains the following information:
Advantages and importance of CE certification
In recent years, the procedure of registration of medical devices in the Russia and the EAEU has become much more complicated and expensive for the manufacturers and the importers. Just the last year, the price of trials increased for 2 or 3 times.
At the same time, the number of laboratories ready to test the medical devices decreased. It is associated with toughening of the requirements to the laboratories themselves (for the part of the Russian Accreditation authority) and to the test results (for the part of expert bodies of the Federal Service for Surveillance in Healthcare). These facts lead to significant increase of expenses and terms of trials.
Concurrently, the laws that regulate the trade of medical devices are changing continuously. Thus, the promised full transition to the EAEU rules is once again postponed, and the national procedure according to the RF rules is temporarily interrupted.
Despite the preliminary decision on the procedure prolongation up to the end of 2022 has been made, the final terms of recovery of the national procedure are still not clear.
For this reason, the alternative way to get the registration certificate in the RF or in the EAEU is to get the CE certificate for the medical device.
It suggests the following advantages to the manufacturers and the importers:
Stages of CE certifications of a medical device
The procedure of CE certification is established by the following documents according to the type of the medical device:
Let’s review the main stages of registration of the medical device in Europe according to the detailed scheme with explanation.
As the scheme shows, the CE certification procedure for the I class medical devices (non-sterile ones and the ones without measuring functions) is significantly simplified and does not require participation of a notified body. Thus, the process is self-declaration. However, the device should also comply with the requirements of the Regulation.
The manufacturer should also implement and keep the appropriate system of quality management, keep and update regularly the technical file, have an authorized representative and submit the required information to the EUDAMED timely. Only under these conditions, the manufacturer has a right to declare the compliance with the requirements of the Regulation, to issue the declaration of conformity and to apply the CE marking to the device.
The degree of participation of a notified body for the other I class devices:
For the devices of the II and the III classes, the participation of a notified body in the regulation process increases significantly as the class increases for the risk also becomes more serious.
European representative of the medical device manufacturer
According to the requirements of regulations MDR 2017/745 and IVDR 2017/746, each manufacturer that is not a member of the European Union, whether he/she plans to sell the products on the EU territory, should have an authorized representative (European Authorized Representative). It is mandatory for all devices, with no regard to their class.
The authorized representative is a legal body assigned in the EU that has a written-made permission to act for the manufacturer that produces the devices outside the European Union. The responsibilities and the duties of the representative are determined by the corresponding regulations.
The main functions and responsibilities of the authorized representative in the EU:
The tasks that the manufacturer assigns to the European authorized representative should be clearly framed and embodied in writing. The tasks that only the manufacturer can accomplish cannot be assigned to the representative, for example, assurance of compliance of the production process with the manufacturer documentation, development and updating of this documentation.
Strictness of the requirements to the authorized representative in the EU depends from the risk class of the device. For the authorized representative should control compliance of the product, the manufacturer and the quality management system with the requirements of the EU regulations, the qualification of the representatives themselves should allow them to work with the medical devices in tough accordance with the requirements of the regulations!
Information on the EU authorized representative is given on the marking of the medical device as a symbol EC REP (see the picture).
The marking for the European authorized representative contains its name, address, and (optionally) contact phone number or e-mail.
Among our official partners, there are organizations that serve as authorized representatives in the European Union for medical devices manufacturers that are not EU residents.
What is a notified body and what are its functions
Notified bodies are organizations authorized by the European committee to estimate compliance of the products in the EU or other countries. Each body should undergo the procedure of official accreditation to confirm its qualification in one or another sphere. To estimate compliance of medical devices, the notified body should be competent in relation to MDR 2017/745 and/or IVDR 2017/746 (for in vitro devices). The list of accredited notified bodies is given at the web-site of the European Committee in section «NANDO notified bodies».
For each Regulation, there are special lists of notified bodies that can provide services for audit, inspection and certification. For Regulation MDR 2017/745, nowadays, there are up to 30 bodies 30, for IVDR 2017/746 – less than 10 (see the pictures).
Results of search for notified bodies (Regulation MDR 2017/745)
Results of search for notified bodies (Regulation IVDR 2017/746)
Information on the notified body that has participated in estimation of the device compliance should be given on the device marking and marked under the CE claim as a four-unit number (NB number).
What is the technical file of a medical device
According to the EU laws, each medical device should be supported with a technical portfolio (technical file). This file contains the requirements to projection, production, trade, use and disposal of the medical device. Both the manufacturer and the authorized representative should be responsible for correctness of the information specified in the technical file.
As the minimum, the technical file should contain the following sections:
Remember that the devices of IIa, IIb and III risk class, as well as the I class devices that are sterile (Is), re-usable surgical tools (Ir), devices with measuring functions (Im) are subject to the audit of technical file by the notified body!
Actually, the certain notified body specifies the detailed requirements to the form and the contents of the technical file.
The minimum period of storage of the technical file documents is 10 years since the date of the production.
The full requirements to the contents of the technical file are given in Annex II to EU MDR 2017/745 and Annex II to EU IVDR 2017/746 for the devices for in vitro diagnostic.
Trials of medical devices for CE certification
During preparation of the technical file, the manufacturer should perform all the required trials of the medical device. The aim of the trials is to confirm compliance with the requirements of MDR 2017/745, IVDR 2017/746 and the standard applicable for the devices.
The trials can be nominally divided into the following groups:
In the technical file, the trial results are given in the section Product verification and validation.
Technical trial is testing performed to determine compliance of the characteristics (features) of the device with the regulation documentation, technical and operational documentation of the manufacturer. It includes determination of overall dimensions, weight, hardness, testing of functional characteristics, check of resistance against climatic and mechanical influence, confirmation of the declared service period, etc.
Testing for bio-compatibility confirm safety of the materials used for production of the medical device at contacting (directly or indirectly) the human body.
Pre-clinical trial is the animal studies with aim to get information on use of the medical device for a living organism before to use it for a human. According to the features of medical devices, preliminary animal study is not applicable for all the devices.
Clinical trial is testing with use of a human as a subject to testing. Such a trial is not always performed. CE certification requires clinical evidence confirming clinical efficiency and safety of the medical device.
For the devices with low risk class, such an information can be received from scientific literature, clinical experience of use of a similar device. For the implantable devices and the devices of the III class, clinical trials with a human as a subject are mandatory (except for some clearly decided cases).
In most cases, you can get the CE certificate without performing clinical trials. However, the manufacturer anyway needs to prepare the Clinical evaluation report that includes analysis of all the available clinical evidence.
Specific trials include those that are required for specific types of devices, for example, testing for electromagnetic compatibility.
Where to test the medical device
СЕ certification allows that some trials can be performed by the manufacturer itself at the production site of the medical device. However, during audit of the quality management system, the notified body should consider the issues of trials performed by the manufacturer.
As a rule, the manufacturer can confirm compliance of the overall dimensions, weight and other parameters that are subject for finishing control during production process. All the trials should be performed according to the test procedures accepted in the EU. If other methods are used, it should be reasonable and the manufacturer itself should validate the methods.
Trials that the manufacturer cannot perform by itself (as a rule, testing for electromagnetic compatibility, sterility, bio-compatibility, etc.) are recommended to be performed in laboratories accredited in the international system ILAC (according to standard ISO 17025) or laboratories accepted by national accreditation bodies of the EU countries. The accreditation area of such laboratories should include the required standards and methods. Notified bodies accept the results received in these laboratories without additional questions.
Pre-clinical trials should be performed in research centers that follow the requirements of standards and recommendations regarding animal studies. The priority during such trials is humanity and absence of unreasonable suffering of animals.
Clinical trials are allowed to be performed only after the ethical committee concludes that it is acceptable to perform clinical trials and only in the medical centers that have experienced at use of the devices similar to those that should be tested.
What is the EUDAMED system and what are its functions
EUDAMED is the unified European database for medical devices and economic operators (subjects of trade) that provides entry into the EU market and trade of medical devices in the EU. Registration in the EUDAMED system is obligatory and is determined by the requirements of regulations ЕС MDR 2017/745 and ЕС IVDR 2017/746.
The system includes six interconnected modules:
Each module should contain the corresponding information on the EUDAMED official web-site. This information is available for any site visitor. Thus, the EU market of medical devices is clear for all the members.
Who should be registered in the EUDAMED
Registration in the EUDAMED is mandatory for:
Pay attention, that any manufacturer should be registered. It does not matter if the manufacturer is the European Union resident or not.
If the manufacturer is not the EU resident, the EUDAMED system should contain the information on the authorized representative of the manufacturer on the EU territory before the manufacturer itself gets registered.
If the economic operator possesses several functions, it should register each function in the system (for example, get registered as the manufacturer and as the authorized representative).
To get the registration number (Single Registration Number, SRN), a Russian manufacturer should address the request to its authorized representative. Then, the authorized representative should accept the request.
After this stage, the Russian representative gets its SRN. If the economic operator gets registered as multi-functional operator (for example, both as the manufacturer and the authorized representative), the operator should get the unique SRN for each registered function.
Terms of issuance of the CE certificate
The terms depend on the following factors:
Moreover, the Regulation EU MDR has set the additional requirements, especially regarding the quality management systems. This makes the process more complicated and time-consuming and, as a result, increases the terms of the certificate issuance.
According to our experience, the average terms of the CE certificate issuance at projecting of the documentation for the device and the quality management system from the very beginning are the following:
If a part of the required documents are available and/or the quality management system is supported by a valid certificate, the specified terms can be significantly reduced.
Validity period of the CE certificate
The CE certificate is usually valid within 3 years. For medical devices with the high risk class, this terms can be reduced to 1 year. The maximum period can be up to 5 years. The CE certificate can be declared as invalid before the validity period ends in case of unsatisfactory control audit by the notified body.
Price of the CE certificate
Total expenses of certification are proportional to the risk class of the medical device. The higher class there higher risk and more complicated the procedure of certification.
Price of the medical device certification in the EU includes the following expenses:
Thus, the approximate price of CE certification can be set only after considering the available documents for the medical device. The client’s wishes regarding choosing of the notified body and the certification authority can also influence the price.
Contact us and inform which medical device you want to certify according to the CE certification, and we’ll calculate the approximate price for free. Just call us and submit the information in any convenient way.
Rules of the CE marking of the medical device
The Regulations establish the strict rules of CE marking. The main requirements to CE marking are given in Annex V and article 20 of Regulation MDR 2017/745:
CE claim applied to the medical device
Where to get the CE certificate
To get the CE certificate, just address to our company. Together, we will find the required scheme of the certificate issuance, prepare the required documents, perform trials and undergo all the inspections by notified bodies and surveillance authorities.
Responsibilities for violations regarding the trade of medical devices certified in the European Union
Violation of the rules of trade of medical devices in the European Union is punishable by civil and even criminal liability measures. In the theory, the following situations are possible when the requirements of the Regulation are failed to comply with:
Distinguishing features of CE certification relatively to registration in the RF and the EAEU
The procedures of registration and CE certification differ significantly:
Thus, CE certification is a step-by-step procedure to make the product and the manufacturer comply with the requirements of the European laws. The result of this procedure is issuance of the CE Declaration of Conformity and application of the CE claim (the CE marking).
Our advantages
The more obvious advantages of cooperation with our company are the following:
These advantages allow to minimize your participation in a complicated process, to reduce expenses and to shorten the period of entry into the European market.
Are you planning to enter your medical devices to the European market? Then contact us in any convenient way to get consulted for free. You can also make an application online. We are glad to help you to get the CE certificate and to solve your questions regarding certification of medical devices for export to Europe.
