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:

  • ЕС IVDR 2017/746 ‒ for the devices for in vitro diagnostic (IVD);

  • ЕС MDR 2017/745 ‒ for other medical devices.

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 (EU Declaration of Conformity, EC Declaration of Conformity);
  • the certificate of compliance (CE certificate).

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:

  • information on the medical device;
  • information on the manufacturer;
  • the number of the notified body (every notified body has its own unique number);
  • regulations and orders the device complies with.

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:

  • much larger trade area, regarding both the population and the purchasing power (the population of Russia – 146 million people, the EAEU – 186 million people, the EU – 453 million people);

  • the CE certificate assures the facilitated procedure of certification of medical devices in Australia, New Zealand, countries of Africa, Latin America, Asia, the Persian Gulf countries, that allows to enlarge the trade areas within short timeframes and at a reasonable price;
  • considering the increase of trials price, state fees and other expenses associated with registration of medical devices on the territory of the Russian Federation or the EAEU, the costs of the CE certificate in most cases do not exceed the costs of registration in Russia or the EAEU, especially for the devices of low risk class;
  • the CE certificate is issued not by the EU government bodies, but by authorized commercial bodies, the so-called notified bodies. It means significantly reduced formalism during the certification procedure and allows shortening of the period required to receive the positive result;
  • the procedure of CE certification is not subject for constant changes that required immediate re-trial, complete reissuance of the documents and repeated tax payment. This assures the minimum expenses for saving of the certificate validity after its issuance;
  • possibility to compensate the expenses of the certification procedure with the help of national programs and subsidies. Such a support is a duty of the Export supporting centers (for example, the Russian export center) and the Ministry of Industry and Trade;
  • when the manufacturer has the CE certificate, it influences positively the company reputation, underlines high quality and safety of the production and means the world-wide acceptance of the devices;
  • the CE marking allows potentially to get a competitive position for tendering events and to ensure support of banks or investors.

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:

  • European regulation MDR 2017/745 – for all medical devices, except for the devices for in vitro diagnostic;

  • European regulation MDR 2017/746 – for medical devices for in vitro diagnostic.

Let’s review the main stages of registration of the medical device in Europe according to the detailed scheme with explanation.

CE scheme

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:

  • class Im – the device with measuring function: a notified body estimates the compliance of the metrological characteristics of the device with measuring function with the established requirements;
  • class Is – the sterile device: a notified body estimates the aspects of sterilization of the medical device during production and maintaining of sterility within the warranty period;
  • class Ir – the multiple-use device: a notified body estimates the aspects of pre-sterile cleaning, disinfection, sterilization, safety measures during the device preparation for repeated use.

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:

  • allows the manufacturer (who is not an EU resident) to place its address on the package;
  • keeps the declarations of conformity, certificates, the technical file, the test reports and other documentation that approves quality and safety of the medical device. Assures validity of the specified documents;
  • interacts with the national authorities (for example, the market surveillance bodies) for the manufacturer company, including taking measures against the risks associated with the device;
  • upon a reasonable request, submits all the information and documentation required to approve the medical device compliance with the requirements to a national expert body;
  • immediately informs the manufacturer on any incident and bad cases associated with the use of the medical device on the EU territory;
  • participates in preparation of the reports according to the results of review of incidents, the device recalls and reclamations;
  • consults the manufacturer on issues of changes in the regulation laws of the European Union in relation to the trade of medical devices.

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).

EC REP

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).

NANDO search results

Results of search for notified bodies (Regulation MDR 2017/745)

NANDO search reults IVDR

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:

  • information on the manufacturer and the EU authorized representative;
  • description and technical characteristics of the device, including information on modified versions and accessories. Information on the unique identification number of the device (UDI);
  • marking and instruction on use (operation manual), manual on technical (service) maintenance (when applicable). The operational documentation should be translated into the languages spoken in the countries where the medical device is planned to be distributed;
  • information on the consumer pack and the transportation pack;
  • detailed information on projection and manufacturing of the device (in a form of block schematic diagrams with description of the processes and their interactions). Please, give the full information on the production process, the vendors and the used materials;
  • risk management according to the requirements of ISO 14971;
  • reports and protocols from a competent body or a laboratory, including any report with the results of tests, trials performed by the manufacturer, the expert body or the accredited laboratory;
  • Declarations of Conformity CE;
  • General Safety and Performance Requirements (GSPR);

  • information on verification and validation. As regards to verification and validation, the European Union pays great attention to the clinical data. Moreover, the clinical data are important at each stage of the service lifetime of the medical device, not only during projection and development, but also after entry into the market. Clinical Evaluation Reports (CER) should contain all-around review of the device design and arrangements, its matter of use, as well as the results deep review of the corresponding literature;
  • information on post-registration control, including post-market surveillance (PMS) plan, post-market clinical follow-up (PMCF) plan and periodic safety update report (PSUR);
  • history of changes made in the technical file.

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:

  • technical testing;
  • testing for bio-compatibility;
  • pre-clinical trials;

  • clinical trials;

  • specific trials.

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:

  • Registration of economic operators – identification of subjects of trade according to their functions (the manufacturer, the authorized representative, etc.);
  • Registration of medical devices – assignment and registration of unique identifiers of the device;
  • Notified bodies and certificates – information on notified bodies and received certificates;
  • Clinical trials and functional characteristics;
  • Post-registration surveillance and informing on negative cases;
  • Regulation bodies’ control over the trade of medical devices.

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:

  • manufacturers of medical devices;
  • authorized representatives of the manufacturers;
  • importers of medical devices to the EU countries.

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:

  • classification of the medical device (risk class, in vitro/not in vitro);
  • the available documents for the medical device to be certified;
  • status of the quality management system, its readiness to get certified for compliance with the requirements of EN ISO 13485;
  • the chosen certification authority and notified body – some bodies are overloaded that influence the audit dates.

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:

  • I class – from 4 months;
  • Is, Ir, Im, IIa classes – from 8 months;
  • IIb class – from 10 months;
  • III class – from 12 months.

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:

  • trials of the medical device to be certified;
  • audit of the quality management system of the manufacturer;
  • audit of the technical file of the medical device (except for the single-usable non-sterile medical devices of the I class);
  • issuance of the CE certificate (for the devices of the IIa class and more risky) and the quality management system certificate;
  • consulting services throughout the period of certification process and development of the required documents.

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:

  • The marking should contain the symbols «CE» placed as it is shown in the picture below;
  • Proportions should be maintained when the symbols are enlarged or lessened;
  • Minimum height of the CE marking is 5 mm. It is allowed to apply a smaller marking to the compact and small medical devices;
  • All the medical devices should have the CE conformity marking, except for the ones manufactured upon a special purchase and the test samples (the devices used for trials);
  • Application of the claim should comply with the general requirements given in article 30 of Regulation (EC) No 765/2008;
  • The claim should be applied in a clearly visible, readable and permanent way (printing, engraving, pressing, etc.) to the device or its sterile package. If such a marking is impossible or it is difficult to provide its reliability, the CE marking should be applied to the device package. The CE claim should be also used in any operating instruction (operation manual) and on any commercial packaging;
  • Under the CE claim, there should be placed the identification number of the notified body that has estimated the compliance of the device. Moreover, this number should be specified in all the commercial materials that mention the compliance of the medical device with the European requirements;
  • If the device falls within the scope of another EU regulation that also presumes application of the CE marking, the CE claim should denote that the device complies with the requirements of this regulation as well.
CE mark

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:

  • Trade of the medical device without the CE claim. For the manufacturers located outside Europe, such a situation is hardly possible. The European customs authorities just can not allow import of medical devices without the CE marking. Moreover, the importers and the authorized representatives are also responsible for the products that entry into the European market. If we even suppose that such a product enters the market, the subjects of trade responsible for distribution should be punished by a significant fine or, in some cases, by prosecution.
  • Illegal application of the CE claim. Such a product is fabricated, so it is also punishable by fines and prosecution for the officials.
  • Entry into the market of the medical devices with the I risk class (non-sterile and without measuring functions) that in some aspects do not comply with the requirements of the EU regulations. Such incompliances are called unintentional non-compliances by the MDR. Such a case is quietly frequent as the entry of the device into the marking takes place without participation of a notified body. When such a non-compliance is found, the manufacturer should take the corrective measures. In case when there are many non-compliances and they are serious, the device can be withdrawn from the circulation in the European Union completely.

Distinguishing features of CE certification relatively to registration in the RF and the EAEU

The procedures of registration and CE certification differ significantly:

  • The national registration system is based on evaluation of the medical device as a separate item. To register it, you should collect the evidence of the device compliance with the regulation documentation. The CE certification is based on evaluation of the procedures that regulate the device development and production. Thus, the registration authorities estimate all the company processes system and the notified body during audit can estimate the way the processes, including the auxiliary ones, are organized.
  • Registration is performed by the government body. Evidence of quality, efficiency and safety is collected specially for registration. Issuance of the CE certificate requires notified bodies that inspect the manufacturer documentation that is used for routine production operations. The number of tries to submit the registration dossier and to fix up the non-compliances and remarks for registration in the RF and the EAEU is limited. The procedure of CE certification as regards evaluation of the manufacturer documentation compliance is performed as a dialogue with the notified body.
  • After receiving the CE certificate, the Russian manufacturer takes responsibility to keep all the processes and the documentation timely updated. The notified body performs periodic inspection. The manufacturer should eliminate non-compliances and deviations according to the inspection results.
  • Medical devices manufactured upon the individual purchase are not subject to CE marking, as well as in case of registration. However, the processes of manufacturing of such devices should be documented, technical documentation should be issued and kept regularly updated, the devices should be classified, and the post-registration surveillance should be provided.

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:

  • we have the in-house expert personnel with at least 5-year average work experience at CE certification of medical devices;
  • we have got more than 20 CE certificates for various medical devices (consumables, diagnostics equipment, implants, etc.);
  • our experts are proficient both in the Russian and the English languages that allows to issue the documents in English. This helps to reduce the projecting terms;
  • we are in a good partnership with the leading European trial centers that perform all the required types of trials. This means reasonable price and possibly reduced terms of any trial according to the requirements of ISO/IEC 17025;
  • all the services are provided together: from preparation of the technical documentation to the audit of the quality management system;
  • wide experience of interaction with certification authorities and notified bodies. We prepare the documents for the certain body according to its requirements;
  • we are registered and located in Russia, and we are open for a dialogue and solving all the issues throughout all the process of CE certification;
  • compatible prices pleasant for clients.

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.

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