for medical products done
with our help!
We take care of your entire CE marking process, including accompanying measures.
All you have to do is affix the CE mark.
Willy Lebherz
Managing Director of easyCE GmbH
Declaration of conformity done!
You will receive a declaration of conformity ready for signature!
Risk assessment completed!
We test your machine against relevant directives and standards
Applicable standards & guidelines applied!
We test your machine against relevant directives and standards
Technical documentation created!
You receive a pragmatic, user-friendly operating manual
CE mark attached!
All you have to do is to affix the CE mark
Over 100 CE markings for medical devices since 2021 and more every day...
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This is what you need to consider when CE marking your medical device
Manufacturers of medical devices must ensure that they comply with the requirements of the EU Medical Device Regulation 2017/745:
1) Products must be designed and manufactured in accordance with the requirements of the Regulation. A risk management system must be established and maintained (Annex I, Section 3).
2) A clinical evaluation shall be carried out in accordance with Article 61 and Annex XIV, including post-market follow-up.
3) For standardised products, technical documentation must be drawn up and kept up to date. This must enable conformity to be assessed and must contain the elements set out in Annexes II and III.
4) After successful conformity assessment, an EU declaration of conformity must be drawn up and the product must be marked with a CE marking (Articles 19 and 20).
5) The requirements of the UDI system and the registration regulations must be met (Articles 27, 29 and 31).
6) A comprehensive quality management system covering all relevant processes and responsibilities must be established and continuously improved.
7) Manufacturers must establish a post-market surveillance system and ensure that all information is clear and understandable. They must take immediate corrective action in case of non-conformity and inform relevant authorities.
8) Manufacturers must provide the competent authorities with all necessary information and cooperate with any corrective action taken.
As a distributor of medical devices, you are responsible for ensuring that only compliant and safe products reach the market. Your main tasks are:
1) Check that the product has the CE marking and an EU declaration of conformity. Make sure the UDI is present.
2) Do not place products that do not comply with the requirements on the market. In the event of non-compliance, inform the manufacturer and, in the event of serious risks, inform the competent authorities.
3) Make sure that storage and transport conditions comply with the manufacturer’s specifications.
4) Maintain a register of complaints and recalls and forward complaints and incident reports to the manufacturer and authorised representative.
5) Provide all necessary information and samples to the authorities upon request and assist the authorities in safety measures.
6) The experts at easyCE are available to answer any questions you may have about conformity. Do you have any doubts about the CE conformity of a machine you have purchased or are about to purchase? easyCE will be happy to check the CE documentation for you.
Manufacturers or their authorised representatives wishing to export products to countries outside the European Union require a free sale certificate issued by the Member State in which the manufacturer or authorised representative is established. It confirms the following points:
1) The manufacturer or authorised representative has a registered establishment in the relevant Member State.
2) The product bears the CE marking and can therefore be traded within the EU, which certifies its conformity with EU regulations.
3) The free sale certificate shall contain the basic UDI-DI of the device, which is deposited in the UDI database pursuant to Article 29.
4) Where a notified body has issued a certificate in accordance with Article 56, the unique identification number of that certificate shall be included in the free sale certificate.
The experts at easyCE will be happy to help you prepare or review the conformity assessment documents, which include product analysis, risk assessment, type plate and the final declaration of conformity. We will also check your operating instructions and their contents for conformity.
An importer is any person or company established in the EU that places medical devices from third countries on the EU market. The main tasks of an importer include:
1) Ensure that the device bears the CE marking, an EU declaration of conformity is available, the manufacturer is known and has appointed an authorised representative. The device must be marked in accordance with EU regulations and contain the required instructions for use. The UDI (Unique Device Identification) must also be present.
2) In case of complaints, suspicion of non-conformity or dangers, inform the manufacturer and the authorised representative (in case of serious dangers or counterfeit products also the authority, if necessary cooperation in recall).
3) The importer must indicate his name, trade name, address and contact information on the product or its packaging. In addition, the product must be registered in the electronic system and the importer data must be completed.
4) Ensure that storage and transport conditions do not compromise product safety and performance and comply with the manufacturer’s specifications.
5) Maintain a register of complaints, non-conforming products, recalls and withdrawals. Make information available to the manufacturer, authorised representative and distributors.
6) Keep a copy of the EU declaration of conformity and relevant certificates.
7) Provide samples of the product or grant access to them upon request.
The experts at easyCE will be happy to help you with any questions you may have about compiling the conformity assessment documents, which include product analysis, risk assessment, type plate and the final declaration of conformity. We will also check your operating instructions and their contents for conformity.
With easyCE is CE mark very "easy"
Approach to CE mark
Diversity and concept of support
Extent of support
Contact during project work
Simplified CE labelling
Maximum flexibility and no red tape
All-round carefree, or modular - as required
Personal CE expert for you, customised to your needs
Other CE service providers
Often without a sense of proportion and unnecessarily complicated
Mostly flexible but often bureaucratic
Mostly flexible in the extent of support
Mostly personal contact
CE software
Follows a standardised process that does not take special features into account
Double burden for you: Software administration + no support for processing
Only according to software scope and purchased modules
No contact
We are convinced that you are looking for
support that takes work off your hands
and does not
cause even more work
Reference projects
Conformity assessment, CE marking and instructions for use for a permeate treatment plant
easyCE supports the entire conformity assessment procedure, including the instructions for use for a system for permeate treatment, i.e. the treatment of water as a precursor to dialysis machines. In terms of design, it was important for the system to maintain and achieve a high degree of purity, which also had to be taken into account during the risk assessment.
Requirements research for dental implants
easyCE supports the research of a wide range of technical requirements for a dental implant. In particular, the technical properties with regard to the angle and inclination of the threads, but also materials such as titanium, were to be found out.
Support with the CE marking of horn eyeglass frames (Class I medical device) and sunglasses
In a challenging project, easyCE ensured the conformity of horn eyeglass frames as accessories to medical devices under the Medical Devices Regulation 2017/745 and of sunglasses under the PPE Regulation 2016/425. We extended the technical documentation to ensure that all required documents such as the risk management plan and the post-market surveillance plan are included.
Our team worked closely with the client to ensure all requirements of the Medical Device Regulation were met, including the general safety and performance requirements set out in Annex I. This included a thorough review of the design and manufacturing requirements to ensure the products met the highest standards.
In addition, we supported the customer in registering in relevant systems to obtain necessary identifications such as SRN (via EUDAMED), DMIDS (via BfArM) and UDI-DI (via IFA). Our expertise and commitment enabled the customer to enter the European market smoothly and streamlined its compliance processes."
Taken into account, among others: Medical Device Regulation 2017/745, PPE Regulation 2016/425, EN ISO 20417:2021, EN ISO 14971:2019 + A11:2021, EN ISO 15223-1:2021, EN ISO 13485:2016 + AC:2018 + A11:2021, EN ISO 12312-1
CE marking for a lubricant according to the Medical Devices Directive
With the help of the Medical Device Directive 93/42/EEC, easyCE also finds the relevant requirements in the case of ambiguous definitions, informs the customer of their obligations and creates the necessary CE documentation around the existing quality management system. A risk management plan, checklists for technical documents, for hazard identification and safety-relevant features, for general safety and performance requirements according to MDR Annex I and a declaration of conformity are created product-specifically in German and English.
CE marking for drug tests
In this specific case of a multi-drug test, the decision on CE marking requirements depends on the user group. While a drug test for law enforcement purposes is exempt, a drug test for medical purposes falls under the new Medical Device Regulations (EU) 2017/745 and In Vitro Diagnostics (EU) 2017/746 as a Class C product. In this project, easyCE adapts the schedule to the customer in a particularly flexible manner, as unexpected problems arise during production. Even after completion of the commissioned project (Technical File, Hazard Identification, Identification of Safety-Related Characteristics, GSPR File, Risk Management Plan, Declaration of Conformity) and handover to the customer, design changes to the product occur. easyCE adapts the conformity documents and advises on necessary changes to the technical documents. Finally, easyCE contacts notified bodies on behalf of the customer and accompanies the customer during registration in EUDAMED to obtain SRN and basic UDI-DI.
Takes into account, among others: Regulation (EU) 2017/745; Regulation (EU) 2017/746
More about project references and history
CE labelling in 3 simple steps
Step 1
Request expert opinion
Ask for our expert opinion free of charge and find out what is necessary for the CE marking of your product. Be prepared to describe your product in broad terms.
Step 2
Get an offer
If your product is subject to CE marking, we offer you our support with the CE marking and all accompanying measures. We would be happy to explain the necessary steps over the phone.
Step 3
Arrange implementation
When you place an order, you will be assigned your own personal CE expert who will carry out your CE marking and accompany you throughout the entire process. Your expert will also be at your side after the CE marking has been successfully completed.
We support you with CE marking and all accompanying measures
Frequently asked question
According to which directives medical devices must bear a CE marking?
The conformity assessment and CE marking of medical devices is still regulated throughout Europe within the framework of three directives until May 26, 2021. These are the following:
- The Medical Devices Directive (93/42/EEC)
- Directive on Active Implants (90/385/EEC)
- In Vitro Diagnostics Directive (98/79/EC)
However, from May 26, 2021, the requirements of the new Medical Devices Regulation (EU 2017/745) and the In Vitro Diagnostics Regulation (EU 2017/746) will apply, replacing the previously mentioned directives. Due to the Corona pandemic, this date has been postponed by a year to May 26, 2021.
Is there protection for existing medical devices whose conformity and CE marking were achieved in accordance with the predecessor directives?
No. There will then be no protection of existing rights and all medical devices must be tested and certified according to the new requirements.
Which types of medical devices must bear the CE marking?
Medical devices are divided into three risk classes according to their intended use:
- Class 1 medical devices: These are non-invasive, non-sterile medical devices that do not have a measuring function. In this case, conformity assessment procedures and CE marking are carried out by the manufacturer, with special elaboration in accordance with specific medical device standards. easyCE is happy to support you with this.
- Class 2 and 3 medical devices: For these products, certification by a "notified body", such as TÜV, DEKRA or MEDCERT, is necessary.
Do software and apps for use in the medical field also require a CE marking?
Yes, software can also be a medical device and require CE marking. For example, clinical information systems, clinical decision support systems and smartphone apps can fall within the scope of the above-mentioned directives and require a conformity assessment. Please contact us to find out more.
What do I have to consider as a manufacturer of medical devices when assessing conformity and CE marking?
easyCE will be happy to help you identify the guidelines and standards that apply to your specific product. We will also be happy to help you with the next step of product analysis and risk assessment.
We are experts in product safety and conformity
Willy Lebherz - Founder and Managing Director of easyCE
- Expert in product safety and conformity since 1995
- Recipient of the "Medal of the Order of Merit of the Federal Republic of Germany", awarded in 1983 by the then Federal President Carl Carstens
- Master of measurement and control technology
- Captain (ret.), Project Officer for Technical Logistics in the Army Material Office and Chief of the Telecommunications Repair Company
easyCE is a digital, dynamic engineering office with a focus on product safety and product conformity. We support manufacturers, operators and dealers in designing products safely and offering them on the market in compliance. We are a "full-service provider" and can take over the entire conformity assessment process for you if you wish. To do this, we support you in carrying out risk assessments, researching standards, product analyses, developing suitable safety precautions, preparing user-friendly technical documentation, coordinating tests and all other accompanying measures. easyCE was founded in southern Germany, but is now active globally.
We know the special features that you need to take into account when CE marking your product and we are happy to help you.