Guide to CE marking for medical devices
under the EU MDR

You have developed a product that qualifies as a medical device or you have a medical device approved in another region and now want to sell it in the European Union or Switzerland. You must have your medical device CE-marked under the EU MDR. In this article, you will get a complete overview of the CE marking journey, with details on the conformity assessment for medical devices according to the EU MDR.

Updated in June 2025

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. Check the differences between a correct and incorrect EU Declaration of Conformity in this article.
• 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. And CE marking is definitely not the last compliance effort in the device’s lifecycle.

Content

Introduction to medical device CE marking

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). For IVDs, read our separate blog article: CE marking for in vitro diagnostic devices under the IVDR.

And, 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.

CE marking roadmap for a medical device

Achieving CE marking for a medical device is a complex, labor-intensive, and winding road, even for regulatory experts.

Newcomers, in addition, need to quickly grasp an overwhelming set of concepts (Notified Body, PRRC, GSPRs, UDI, PMS) and their interrelated requirements. The diagram below illustrates the complexity.

In brief, the steps involved in CE-marking of medical devices are:

STEP 1

Based on the intended purpose assigned by the manufacturer: determining whether the product is governed by the EU MDR, including for Annex XVI products (i.e. product qualification) and determining the device class per EU MDR Annex VIII (i.e. device classification).

STEP 2

Identifying all regulatory requirements that apply to the product, i.e. the General Safety & Performance Requirements (GSPRs) in EU MDR Annex I, as well as the essential requirements of any overlapping or parallel EU legislation that might be relevant to the product’s characteristics (e.g. Batteries Regulation, Packaging & Packaging Waste Regulation, Radio Equipment Directive, RoHS Directive, WEEE Directive, General Data Protection Regulation, Ecodesign Regulation, AI Act), some of which require simultaneous CE marking.

STEP 3

Setting up or upgrading the manufacturer’s quality management system (QMS), which entails identifying EU MDR specific process requirements and a duly qualified Person Responsible for Regulatory Compliance (PRRC), as well as, where applicable, an appropriate Notified Body and EU Authorized Representative (EU-REP).

STEP 4

Gathering the necessary evidence of conformity with the GSPRs and any other requirements identified in Step 2, and documenting such evidence in a technical documentation according to EU MDR Annexes II and III. The evidence of conformity includes the risk-benefit assessment supported by the clinical evidence, in alignment with EU MDR Annex XIV. Make sure you follow the Team-NB’s best practice guide on technical documentation, which is very detailed and provides tips and pitfalls from Notified Body’s experience. 

To complete this step, the manufacturer must assign the Unique Device Identifier (UDI) to the medical device and prepare the necessary labelling elements, including their translation into the mandatory languages in EU/EEA countries where the manufacturer intends to sell the device.

STEP 5

Where the device class is higher than Class I, lodging an application for the appropriate Conformity Assessment route with the selected Notified Body. For Class I devices that are not sterile, with measuring function or reusable surgical instruments, Step 5 does not apply.
If the product simultaneously falls under other EU legislation that also requires conformity assessment, more than one Notified Body may be necessary.
Certification by the Notified Body involves inspection of the manufacturer’s QMS and technical documentation.

STEP 6

Upon satisfactory certification by the Notified Body or, for Class I devices, upon completion of Step 4, signing the EU Declaration of Conformity and affixing the CE mark on the medical device.

Many medical devices are simultaneously subject to other EU harmonized legislation that also calls for CE marking, e.g. Batteries Regulation, Packaging & Packaging Waste Regulation, Radio Equipment Directive, RoHS Directive, Ecodesign Regulation. In such a case, the manufacturer must issue a single EU Declaration of Conformity, covering all applicable legislation.

Last, before the device can be sold, the manufacturer must ensure registration in the European database, EUDAMED.

Now, conformity with the EU MDR does not end with CE marking. It is a continuous process throughout the device’s lifecycle that entails device/process change management as well as Post-market Surveillance (PMS) and Vigilance activities, while keeping abreast of never-ending regulatory changes that impact the device or its related processes. See chapter: EU MDR compliance in the post-market phase.

Conformity Assessment routes under the EU MDR

Based on the device class, the medical device manufacturer must determine the appropriate conformity assessment procedure, as outlined in Article 52 of the EU MDR.

Investigational devices, i.e. devices used 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.

Conformity assessment carried out by the manufacturer

The medical device manufacturer has sole responsibility for the conformity assessment of Class I devices that are not sterile, reusable or have a measuring function. No Notified Body is involved. Therefore, these Class I devices must bear just the CE mark, i.e. without a Notified Body identification number. Before releasing a medical device to the market, the manufacturer must ensure the technical documentation is complete according to EU MDR Annexes II and III, so that the EU Declaration of Conformity can be issued with the contents set forth in Annex IV of the EU MDR.

Although crafting a compliant EU Declaration of Conformity by merely following Annex IV of the EU MDR seems easy, in our regulatory consultancy role, we frequently see incorrect ones from Class I manufacturers. To ensure you get this right, here you have a comparison between an incorrect and correct EU Declaration of Conformity for a Class I medical device under the EU MDR. Check out the differences!

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

Remember that overlapping legislation calling for CE-marking might apply (e.g. Packaging & Packaging Waste Regulation), in which case the above example should be merged with the corresponding EU Declaration of Conformity requirements into a single one.

For details on how to ensure compliance for Class I devices, read our bespoke blog article: Class I medical device manufacturers under the EU MDR.

Conformity assessment carried out by a Notified Body

Notified Bodies are private organizations designated by the competent authority of a EU Member State to carry out the conformity assessment under a specific EU legislation. To better understand the Notified Body role, read EU Notified Bodies for medical devices and IVDs.

The following medical devices require the involvement of a Notified Body in the conformity assessment:

• 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

Devices assessed with the involvement of a Notified Body must bear a CE mark that includes the identification number of the responsible Notified Body. For example, CE0123 for CE marking with TÜV SÜD as Notified Body, whose identification number is 0123.

For device classes where manufacturers have a choice of conformity assessment routes, Annex IX is typically preferred over a combination of Annex X and any part of Annex XI, because it is more efficient. Within a single application to the Notified Body, Annex IX covers the assessment of the quality management system and the technical documentation.

Conversely, Annex X (Type Examination) only covers the technical documentation assessment and requires additional certification. Once the EU Type Examination certificate is obtained, the manufacturer needs to lodge a subsequent application to the Notified Body for either Quality Assurance (Annex XI Part A) or Product Verification (Annex XI Part B).

Notified Bodies issue 5 different types of certificates depending on the conformity assessment procedure:

Each certificate may refer to only one conformity assessment procedure.

For a given medical device, the following combinations of certificates are possible: 

• EU QMS certificate under Annex IX only.
• EU QMS certificate and EU technical documentation assessment certificate under Annex IX.
• EU Type-Examination certificate in Annex X and EU Quality Assurance certificate in Annex XI Part A.
• EU Type-Examination certificate in Annex X and EU Product Verification certificate in Annex XI Part B.
• EU Quality Assurance certificate under Annex XI Part A (section 10) only.
• EU Product Verification certificate under Annex XI Part B (section 18) only.

After the successful conformity assessment, the manufacturer can affix the CE mark on the medical device and issue a EU Declaration of Conformity in accordance with EU MDR Annex IV, attesting that the devices covered conform to the regulation, which means conformity both with the GSPRs and with any product-related processes required by the EU MDR.

EU MDR compliance in the post-market phase

Achieving CE-marking under the EU MDR is only a milestone in the lifecycle of a medical device. 

Conformity with the EU MDR has to be maintained in the post-market phase and this entails monitoring relevant regulatory changes (e.g. new/updated MDCG guidance documents, new/updated Harmonised Standards) and assessing their impact on devices and processes, managing device/process changes, keeping the technical documentation up to date, as well as conducting the mandatory Post-market Surveillance (PMS) and Vigilance activities.

Manufacturers must implement a solid change management process to ensure that the impact of all changes to device design and device-related processes is appropriately assessed. Such impact might entail, for example: gathering additional evidence of conformity with the GSPRs, validating production or quality control processes, reviewing the instructions for use, or training affected personnel on new regulatory requirements.

In addition, the output of PMS activities may trigger the need to update the device risk assessment, labelling, design or production processes. And, in all cases, the results from Post-market Clinical Follow-up (PMCF) activities must be reflected in updates of the clinical evaluation.

When the conformity assessment involves a Notified Body (i.e. for devices above Class I, and for custom-made devices that are Class III implantables), the manufacturer must inform the Notified Body of the following changes ahead of implementation:

• Substantial changes to QMS or the device range covered by the Notified Body’s certificate.
• Device changes that could affect its safety and performance or the conditions for use of the device.

Such changes might trigger verification audits or reassessments and result in certificate supplements.

Because Notified Body’s certificates have limited validity, re-certification audits are required at the end of the certification cycle, which lasts a maximum of 5 years. In between re-certification audits, planned, annual surveillance audits are conducted by the Notified Body. In addition, Notified Bodies must conduct at least 1 unannounced audit in-between surveillance audits. These audits are illustrated in the below infographic.

In brief, our recommendation to manufacturers who achieve CE marking for the first time after a labor-intensive preparation is to save resources for the equally intense post-market phase. The costs of CE marking maintenance (e.g. PMCF activities, adapting to ever-increasing regulatory requirements, Notified Body’s assessment of changes, as well as surveillance, unannounced, and recertification audits) must be part of the equation of bringing a medical device into the EU/EEA market as well as in Switzerland.

EU MDR compliance at the end of the medical device lifecycle

Even the end of the medical device lifecycle is subject to requirements in the EU MDR. 

Most notoriously, the new Article 10a, on the obligations to inform competent authorities and downstream economic operators about the interruption or discontinuation of supply of devices for which it is reasonably foreseeable that the interruption or discontinuation could result in serious harm or a risk of serious harm to patients or public health in one or more EU Member States. The information must be relayed at least 6 months prior to the interruption/discontinuation of supply, which is only possible if it is not due to sudden and unexpected external or internal circumstances. To ensure compliance, the manufacturer must have in place means to estimate the potential impact of interruption/discontinuation of supply for the devices placed on the market. This needs substantial preparation, and the EU Commission’s Q&A document on Article 10a provides some guidance on how to proceed.

Note that Switzerland has not carried over EU MDR Article 10a into the Swiss Medical Device Ordinance (SR 812.213, MedDO). As such, Swissmedic only requires notification of de-registration of devices subject to registration, which currently is limited to custom-made devices, repackaged/relabelled devices, devices manufactured and used within healthcare institutions, and Procedure Packs or Systems assembled by Swiss entities.

Even when Article 10a does not apply, manufacturers intending to discontinue a CE-marked device model should establish a plan and checklist to ensure that the following activities are considered:

1. Determination of the official date when the last device unit is placed on the market, so that the document retention period starts running. Further consideration should be given to the fact that the lifetime claimed by the manufacturer might be longer than the mandatory retention period (10 years or, for implantable devices, 15 years).
2. Establishing appropriate means of archiving all technical documentation versions, EU Declarations of Conformity, and where applicable, Notified Body’s certificates for the mandatory retention period, so that the information can be located and retrieved upon request.
3. Where applicable, ensuring that servicing can be maintained for the claimed device lifetime (e.g. production of spare parts, up-to-date repair instructions and available equipment/tools).
4. Preparing and distributing in a timely manner an appropriate communication for customers.
5. Where applicable, informing the Notified Body of the discontinuation of the model, so that any open actions (e.g. non-conformities, upcoming audits, technical documentation sampling plans) can be adapted.
6. Maintaining the ability to fulfill Vigilance obligations and related product liability until the end of the claimed device lifetime, as applicable to the last device unit placed on the market.

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

• Is my product a medical device in Europe? How to determine if your product requires medical device CE marking
• CE marking for in vitro diagnostic devices under the IVDR
• EU Notified Bodies for medical devices and IVDs
• Understanding Harmonised Standards for medical devices and IVDs
• The intended purpose – or, what does your medical device do?
• Class I medical device requirements for manufacturers under EU MDR
• Medical device classification under the EU MDR
• Certification of a Quality Management System according to ISO 13485
• EU MDR language requirements – what manufacturers and distributors need to know
• Post-market Surveillance (PMS) for medical devices under the EU MDR and IVDR
• Medical device and IVD Vigilance in the EU and Switzerland

This version of the article replaces the previous one dated 2-Nov-2022. It has been overhauled to provide a step-by-step roadmap on CE-marking for medical devices under the EU MDR, additional tips on the post-CE marking and end of lifecycle phases, as well as examples from Decomplix’ experience as regulatory consultants.