How to obtain a CE mark for a medical device

In order to place a medical device on the EU market, it must meet General Safety and Performance Requirements (GSPRs) and comply with all applicable EU directives. After successfully completing a conformity assessment procedure, conformity is made visible by a CE mark on the medical device.

Replaces the version of April 2020

Key takeaways

  • The conformity assessment process to achieve CE marking increases in complexity as the device risk class increases.
  • By signing the EU Declaration of Conformity for a medical device, the manufacturer is attesting that the device and its related process comply with the applicable requirements in the EU MDR. A manufacturer should only sign if such compliance is true and can be demonstrated.
  • Affixing the CE mark is not necessarily the last step before selling your device. You still need to ensure registration and labeling translations for the country of interest.

Content

Introduction

Since 2017 medical devices have been governed by Regulation (EU) No. 2017/745 (MDR) and in vitro diagnostic devices by Regulation (EU) No. 2017/746 (IVDR). Any new devices must be developed, manufactured and maintained in accordance with these regulations. Proving this is done through conformity assessment.

The present article focuses on medical devices that are not in vitro diagnostic devices (IVDs). To find out whether your product is a medical device or an IVD or another product category, see: Is my product a medical device in Europe? How to determine if your product requires medical device CE marking.

Approval procedures to obtain a CE Mark for a medical device

For the purpose of conformity assessment procedures, medical devices are grouped into four risk classes. The classification rules are based on the vulnerability of the human body and consider the potential risks that are associated with the technical design and manufacturing of the devices.

Only medical devices of the lowest risk class do not need to involve a notified body in the conformity assessment procedure. Notified bodies are independent, state-authorised third-party companies that carry out the conformity assessment on behalf of the medical device manufacturers.

The manufacturer is free to choose the notified body as long as the notified body is accredited by the competent authority in the relevant EEA state, Switzerland, or Turkey and has the relevant product group within its scope. Information on the notified bodies can be found in the information system NANDO (New Approach Notified and Designated Organisations).

A formal submission for CE mark certification must be filed by the manufacturer to the selected notified body. It is not possible to apply to various notified bodies simultaneously and it is not easy to change notified bodies once the certification process has started.

The risk class determines the conformity assessment route

In Europe, medical devices are divided into four risk classes: Classes I, IIa, IIb, and III. The designation is made according to Annex VIII of the MDR. Class I devices can additionally be: sterile (Class Is), with measuring function (Class Im), or surgically reusable (Class Ir). Note that similar devices  may belong to different classes, depending on the intended purpose, the duration of use, and the anatomical position of the product. Here you will find detailed explanations on the subject of intended purpose of medical devices.

Depending on the risk class, the conformity assessment can be carried out by the manufacturer or the assessment as well as periodic controls must be carried out by a notified body. Manufacturers of the devices of all risk classes have to compile technical documentation to prove the fulfillment of the General Safety and Performance Requirements (GSPRs) set forth in Annex I of the MDR.

Here you can find more on medical device risk classification.

Classification by risk and conformity routes under the MDR 

Once the risk class has been determined, the manufacturer must determine the conformity assessment procedures as outlined in Article 52 of the MDR.

Investigational devices, i.e. devices assessed in a clinical investigation that are not yet CE-marked or CE-marked for a different intended purpose than the one being investigated, do not bear a CE mark and do not need to undergo a conformity assessment procedure, although specific requirements apply before the investigational device can be used on patients.

The below table summarizes the applicable conformity assessment routes based on the device classification.

Classification

Conformity Assessment Options

Class I

EU Declaration of Conformity, upon compilation of the technical documentation in accordance with Annexes II and III (without notified body involvement)

Class Is,
Class Im,
Class Ir

In accordance with Chapters I and III of Annex IX

OR

Part A of Annex XI

Class IIa

In accordance with Chapters I and III of Annex IX (including a technical documentation review of at least one representative device per generic device group)

OR

Compiling technical documentation in accordance with Annexes II and III together with Conformity Assessment as specified in Section 10 or 18 of Annex XI

Class IIb

In accordance with Annex IX (including a technical documentation review of at least one representative device per generic device group)

However, for implantable Class IIb devices (exceptions listed in Article 52) a technical documentation review is required for every device.

OR

Annex X (EU Type Examination) in combination with Annex XI

Class III

In accordance with Annex IX

OR

Annex X (EU Type Examination) in combination with Annex XI

Custom Made – Class III

In accordance with Chapter I of Annex IX

OR

Part A of Annex XI.

Custom Made –
all other Classes

In accordance with Annex XIII (without notified body involvement)

System and
Procedure Pack

In accordance with Article 22 (without notified body involvement)

Notified bodies issue different types of certificates depending on the conformity assessment procedure:

  • For the manufacturer’s quality management system: the EU QMS certificate (under Annex IX), or EU quality assurance certificate (under Annex XI).
  • For the device: the EU technical documentation assessment certificate (under Annex IX). EU type-examination certificate (under Annex X) or EU product verification certificate (under Annex XI).

Annual surveillance audits are conducted by the notified body and unannounced audits can be decided by the notified body in-between surveillance audits. 

After the successful conformity assessment, the manufacturer can place the CE mark on the products and issue a Declaration of Conformity for the respective product, in accordance with MDR Annex IV, attesting that the products conform to the regulation, which entails conformity both with the GSPRs and with any product-related processes required by the MDR.

Most manufacturers of devices higher than risk class I choose the conformity assessment route according to Annex IX, This conformity process is based on an assessment of the quality management system as well as technical documentation and simplifies the CE marking of their other devices.

The notified body audits the manufacturer’s quality management system according to the MDR (where a pre-existing certification to the harmonized standard ISO 13485 provides presumption of conformity) and, depending on the risk class, the audit also includes a review of the technical documentation or design dossier. The purpose of the review is to ensure that sufficient design controls are in place, and that the established processes to create and maintain a technical documentation/design dossier are adequate.

Conformity assessment carried out by the manufacturer

Class I devices that are not sterile, reusable or have a measuring function are marked with just the CE mark, i.e. without a notified body identification number. This is because the manufacturer has sole responsibility for the conformity assessment and a notified body is not involved in the process.

Before releasing product to market the manufacturer declares conformity in an EU Declaration of Conformity. In addition, Class I devices placed on an EEA country, Switzerland or Turkey must be registered via the UDI module in EUDAMED or, in some cases, through the national competent authority. Registration in EUDAMED is incumbent upon the manufacturer, irrespective of the country where it is located. Registration with national competent authorities, wherever still applicable, is usually required from local manufacturers or authorised representatives.

Conformity assessment carried out by a notified body

The following medical devices require an assessment and periodic review by a notified body:

  • Class I sterile medical devices (Is)
  • Class I medical devices with measuring function (Im)
  • Class I surgically reusable medical devices (Ir)
  • Class IIa, IIb and III medical devices
  • Class III custom-made devices

A successful conformity assessment by the manufacturer presupposes that the product meets all applicable GSPRs. The conformity requirements increase with the type of device and the risk class. Written evidence of this conformity must be available for each product (such as technical documentation and batch records) and duly maintained throughout the device lifecycle. This means reviewing all impacted documents upon device changes, changes in processes and changes in regulations, official guidelines or harmonized standards that affect device conformity.

Note also that the information supplied with the device (labels, instructions for use) must be available in the required languages of the countries where the CE-marked device is intended to be sold. For more information on this topic, see: EU MDR language requirements – what manufacturers and distributors need to know.

Devicesthat were assessed with the involvement of a notified body are to be marked with a CE mark and the identification number of the responsible notified body.

For medical devices containing medicinal substances that qualify as medical devices, the notified body carries out the necessary consultations with European Medicines Agency (consultation procedure).

 

How to Obtain a CE Mark for Medical Device

The EU Declaration of Conformity is a legal document that must be structured per MDR Annex IV; all information must be correct and clearly identify the devices.

How Decomplix can help

Decomplix provides expert assessment of your situation and a complete roadmap to obtaining a CE mark for your medical device. You can learn more about our services here.

Further reading

 

Pictures: niroworld, NONWARIT/ Shutterstock.com

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