CEMARKING for medical products MADE EASY!
WITH OUR EXPERT SUPPORT
All you have to do is affix the CE mark.
Willy Lebherz
Director & founder of easyCE GmbH
Declaration of conformity done!
We support you in preparing all MDR-compliant documentation – from risk management and clinical evaluation to usability engineering and QMS development.
Risk assessment completed!
Together, we identify, evaluate and document all risks in accordance with ISO 14971 and ensure complete traceability to requirements and tests.
Clinical evaluation conducted in accordance with MDR!
We support you in preparing the Clinical Evaluation Report (CER) and in demonstrating the safety and performance of your medical device.
EUDAMED & UDI-DI registration completed!
We assist you with registering your medical device in EUDAMED and recording the UDI-DI for your product.
QMS according to ISO 13485 implemented!
We support you in setting up your quality management system in accordance with ISO 13485 and prepare you optimally for certification by a notified body.
Over 100 CE markings for medical devices since 2021 and more every day...
This is what you need to consider when CE marking your medical device
AS PRODUCER OF MEDICAL PRODUCTS
AS DEALER OF MEDICAL PRODUCTS
AS EXPORTER OF MEDICAL PRODUCTS
AS IMPORTER OF MEDICAL PRODUCTS
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.
Only with easyCE, CE marking is worry-free
Approach to CE marking
Flexibility and concept of support
Scope & scale of support
Contact during project work
Simplified and pragmatic approach to CE marking to ensure compliance
In line with to your needs, our experts will take you along the CE marking journey
You choose our support model: From "One-stop-shop full service", to partial and modular - whatever you prefer
First things you receive your dedicated, personal CE expert who will support you along the entire process
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 simplify CE-marking not the opposite
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.
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
Conformity assessment procedure and CE marking for veterinary cauterization devices
easyCE successfully supports CE marking up to the ready-to-sign Declaration of Conformity for handheld cauterization devices. The implementation of requirements according to EN 60335-1 for electrical safety represents a central aspect. A particular challenge is compliance with electromagnetic compatibility according to the EMC Directive 2014/30/EU, which was solved through targeted measures such as shielding and interference suppression capacitors in accordance with EN 55014-1.
Considering: 2014/35/EU, 2014/30/EU, 2011/65/EU
Conformity assessment procedure and CE marking for an anesthetic gas scavenging system in medical environments
easyCE successfully supports CE marking up to the ready-to-sign declaration of conformity for a system designed to scavenge anesthetic gases. According to EN ISO 80601-2-13, special safety requirements for anesthesia workstations had to be met. The challenge was validating flow rates for effective gas extraction while ensuring electrical safety according to EN 60601-1 for use in medical environments. Through precise validation measurements, the system's consistent performance was demonstrated.
Considering: 903/85/EEC
Learn more about our project references and success stories
Get CE-marking done 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
Receive our offer
If your product is subject to CE marking, we offer you our support with the CE marking and all accompanying measures. We will be happy to explain necessary steps on the phone.
Step 3
We get it done
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 questions
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.
Trust the experts of product safety and compliance
Willy Lebherz - Founder and Managing Director of easyCE
- Expert in product safety and compliance, 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.