CE-marks for medical devices – Conformity to the MDR

CE-marks for medical devices – Conformity to the MDR
CE-Kennzeichen für Medizinprodukte
The CE-mark

The CE-mark of a medical device (EC-certificate) is the basis for marketing in the EU. The advantage of the CE-mark is, that this single certificate allows marketing in all member states of the EU. With the CE-mark on a medical device, its conformity with the regulatory requirements are confirmed. These general requirements on safety and performance define e.g. an acceptable benefit-risk-ratio, the usability of the medical device and a safety level with no unacceptable risks. These are defined in the medical device regulation (MDR, EU 2017/745), which will come into force in May 2021. Until then, the general requirements of the medical device directive (MDD, EU 93/42/EWG) are effective.

The function of risk classes for the CE-mark of medical devices
Medical devices are classified into different risk classes (I, Is, Ir, Im, IIa, IIb, III). The medical device is classified according to the intended use as defined by the manufacturer and the thereby resulting risks.
  • Risk class I: Products and consumer articles for external, non-invasive use with low risk potential (Is: sterile products, Im: products with measuring function, Ir: Reusable surgical equipment [introduced with the MDR])
  • Risk class IIa: Invasive products with short-time application (< 30 days), e.g. catheters, cannulae
  • Risk class IIb: Products with general enhanced risk, e.g. ventilators, implants with long-term application
  • Risk class III: Products with high risk potential, e.g. endoprosthesis, pacemakers

Dependent on the risk class of the medical device, conformity of the medical device and the respective documentation is assessed by the manufacturer himself or by a notified body.

Notified bodies are companies, which examine the conformity assessment done by the manufacturer. They are commissioned by the manufacturer. The information about which notified body is allowed to examine which conformity assessment is given in a database. Currently, notified bodies are heavily booked. Consequently, manufacturers should search for a notified body timely!
The conformity assessment for simple class I medical devices is performed in self-responsibility of the manufacturer and these devices are labelled with an CE-mark without identification number. The conformity assessment for all other medical devices (classes Is, Ir, I, m, IIa, IIb, III, without customer-made products and products for clinical trials) is performed in collaboration with notified bodies.

The conformity assessment procedure

The purpose of the conformity assessment procedure is to prove that all requirements for a CE mark are fulfilled. The three main criteria are the safety and performance of the medical device and the surveillance by the manufacturer during the whole life cycle of the medical device.
The manufacturer is the company labeled on the medical device. It is not required that the manufacturer produces the medical devices, but it markets it in its name and is responsible for the product in the EU (if the company headquarter is in the EU, if not, a responsible person for the EU has to be announced).
The manufacturer should pay attention to the relevant standards for the product, especially to the harmonized European standards (see list) to fulfill the requirements for the medical device. In addition, according to the MDR, every manufacturer needs a quality management system, usually structured according to ISO 13485.
The technical documentation is the basis for the CE mark and contains all relevant information about the medical device (e.g. clinical evaluation, instruction for use, EU type-examination, risk assessment and risk management, usability reports…). The manufacturer creates and signs the Declaration of Conformity. Subsequently, a notified body examines the conformity assessment procedure (except for class I medical devices).

According to the risk class of the medical device, the manufacturer can choose between different conformity assessment procedures. An overview is given in the table below:

 Conformity assessment for products of the risk class I
Risk class IRisk class IsRisk class ImRisk class Ir
Option 1Declaration of manufacturer according to article 19 AND drafting of the technical documentation (annex II and III)
AND
Complete quality management system according to ISO13485
(annex IX, chapter 1+3)
Assessment by notified body
OR
Quality assurance of products by quality management system for the production according to ISO13485
(EU type-examniation needed)
(annex XI, part A)
Assessment by notified body
 Conformity assessment for products of the risk classes IIa, IIb and III
Risk class IIaRisk class IIbRisk class III
Option 1Complete quality management system according to ISO13485
AND
Assessment of the technical documentation
(annex IX, chapter 1+3)
Complete quality management system according to ISO13485
AND
Assessment of the technical documentation
(annex IX, chapter 1+3 and chapter 2)
OR
Option 2Drafting of the technical documentation
(annex II and III)
EU type-examination
(annex X, including technical documentation)
Assessment by notified body
AND
Examination of product
(annex XI, part B, section 11 or 18)
Assessment by notified body
Quality assurance of products by quality management system according to ISO13485
(annex XI, part A)
Assessment by notified body
OR
Examination and testing of every product
(annex XI, part B)
Assessement by notified body

Note: For every option of the conformity assessment, the top module AND one of the “OR” modules has to be chosen. All references are directed to the annexes of the MDR.

Die einzelnen Anhänge zu den Konformitätsbewertungsverfahren nach der The different annexes of the MDR might contain specific sections for the different risk classes, leading to differences in the same conformity assessment procedure for medical devices of different risk classes. Contrary to the MDD, the option of final control of the products “Product quality assurance according to ISO 13485 (Annex VI MDD)” for medical devices of class Is, IIa and IIb is no longer available in the MDR.

After a successful examination of the conformity assessment procedure by the notified body, an EC certificate is issued which is valid for five years. After five years a renewal of the certificate is necessary. Afterwards, the manufacturer labels the medical devices with the CE mark together with the identification number of the respective notified body (e.g. CE0123).

CE-marks for medical devices according to MDR starting on 26.05.2021

With the MDR coming into force (planned for the 26.05.2020, now postponed for one year) only medical devices conform to the MDR are allowed to be marketed by the manufacturer.

Medical devices with a CE mark conform to the MDD can still be marketed until the end of validity of the certificate, latest the 26.05.2024. In addition, class I medical devices (with CE marks only by the declaration of the manufacturer) which are classified in higher risk classes according to the MDR are also allowed to be marketed until the 26.05.2024. Notably, it is required that these medical devices continue to be in conformity with the MDD and that the manufacturer does not introduce relevant changes.
In addition, vigilance, market surveillance and post-market surveillance as well as registration of economic operators and products have to be in conformity with the MDR!

The proof of conformity of a medical device might be a very complex and individual process, dependent on different variables for every individual manufacturer (e.g. dependent on an existent QM system). Acquiring the expertise of a reputable regulatory affairs consultant might be advantageous for the manufacturer to find the most efficient way to a positive conformity assessment and consequently to the CE mark. In case you need support on the way to the CE mark for your medical device or you have further questions, do not hesitate to contact us. Together with you, the team of YES will develop a suitable strategy and supports you upon creation of the necessary documents, e.g. the clinical evaluation or the whole technical documentation. YES – your external support!

Sebastian Neuss

DE