CE MARKING FOR
MEDICAL PRODUCTS
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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 in accordance with Article 61 and Annex XIV shall be carried out, including post-marketing surveillance.
3) Technical documentation must be prepared and kept up to date for standardised products. This must enable an assessment of conformity and contain the elements from Annexes II and III.
4) After a successful conformity assessment, an EU Declaration of Conformity must be drawn up and the product must be CE labelled (Articles 19 and 20).
5) The requirements of the UDI system and the registration regulations must be fulfilled (Articles 27, 29, and 31).
6) A comprehensive quality management system that covers all relevant processes and responsibilities must be established and continuously improved.
7) Manufacturers must set up a post-market surveillance system and ensure that all information is clear and understandable. They must take immediate corrective action in the event of non-compliance and inform the relevant authorities.
8) Manufacturers must provide the competent authorities with all necessary information and co-operate with corrective measures.
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 bears the CE marking and that an EU Declaration of Conformity is available. Make sure that the UDI is available.2) Do not place products on the market that do not fulfil the requirements. Inform the manufacturer in the event of non-compliance and the competent authorities in the event of serious hazards.
3) Ensure that the storage and transport conditions comply with the manufacturer's specifications.
4) Keep a register of complaints and recalls and forward complaints and incident reports to the manufacturer and authorised representative.
5) Provide the authorities with all necessary information and samples on request and support the authorities with safety measures.
The experts at easyCE are available to answer any questions you may have about compliance. Do you doubt the CE conformity of a machine you have purchased or is about to purchase? easyCE will be happy to check the CE documentation for you.
Manufacturers or their authorised representatives who wish to export products to countries outside the European Union require a certificate of free sale issued by the Member State in which the manufacturer or authorised representative is based. It confirms the following points:
1) The manufacturer or authorised representative has a registered place of business in the relevant Member State.2) The product bears the CE mark and can therefore be traded within the EU, which certifies its conformity with EU regulations.
3) The certificate of free sale contains the basic UDI-DI of the device, which is stored in the UDI database in accordance with Article 29.
4) If a notified body has issued a certificate in accordance with Article 56, the unique identification number of that certificate shall be included in the certificate of free sale.
The experts at easyCE will be happy to help you prepare or check the conformity assessment documents, which include product analysis, risk assessment, nameplate and the final declaration of conformity. We also check your operating instructions and their contents for conformity.
An importer is any person or company based in the EU who places medical devices from third countries on the EU market. The most important tasks of an importer include:
1) Ensure that the product bears the CE marking, an EU Declaration of Conformity is available, the manufacturer is known and an authorised representative has been appointed. The product must be labelled in accordance with EU regulations and contain the required instructions for use. The UDI (Unique Device Identification) must also be present.2) In the event of complaints, suspected non-conformity or hazards, inform the manufacturer and the authorised representative (in the case of serious hazards or counterfeit products, also inform the authorities and, if necessary, cooperate with a recall).
3) The importer must affix his name, trade name, address and contact information to the product or its packaging. In addition, the product must be registered in the electronic system and the importer data must be added.
4) Ensure that storage and transport conditions do not affect product safety and performance and comply with the manufacturer's specifications.
5) Keep a register of complaints, non-conforming products, recalls and withdrawals. Provide information 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 upon request.
The experts at easyCE will be happy to help you with any questions you may have about compiling the documents for conformity assessment, which include product analysis, risk assessment, nameplate and the final declaration of conformity. We also check your operating instructions and their contents for conformity.
Als Hersteller sind Sie in vielfältiger Art und Weise vom Thema CE betroffen.
- Sie stellen CE-kennzeichnungspflichtige Produkte her.
- Sie nutzen für die Produktion CE-kennzeichnungspflichtige Maschinen und Betriebsmittel.
- Sie kaufen CE-kennzeichnungspflichtige Bauteile ein, die in Ihren Produkten aufgehen.
easyCE unterstützt Sie in allen drei Aktionsbereichen mit Ende-zuEnde Unterstützung. In Recherche von Richtlinien, Verordnungen und Normen. Ebenso wie der Erstellung der Produktanalyse, Risikobeurteilung, möglichen Messungen von Testlaboren, Kommunikation mit benannten Stellen etc.
Als Hersteller sind Sie in vielfältiger Art und Weise vom Thema CE betroffen.
- Sie stellen CE-kennzeichnungspflichtige Produkte her.
- Sie nutzen für die Produktion CE-kennzeichnungspflichtige Maschinen und Betriebsmittel.
- Sie kaufen CE-kennzeichnungspflichtige Bauteile ein, die in Ihren Produkten aufgehen.
easyCE unterstützt Sie in allen drei Aktionsbereichen mit Ende-zuEnde Unterstützung. In Recherche von Richtlinien, Verordnungen und Normen. Ebenso wie der Erstellung der Produktanalyse, Risikobeurteilung, möglichen Messungen von Testlaboren, Kommunikation mit benannten Stellen etc.
Als Hersteller sind Sie in vielfältiger Art und Weise vom Thema CE betroffen.
- Sie stellen CE-kennzeichnungspflichtige Produkte her.
- Sie nutzen für die Produktion CE-kennzeichnungspflichtige Maschinen und Betriebsmittel.
- Sie kaufen CE-kennzeichnungspflichtige Bauteile ein, die in Ihren Produkten aufgehen.
easyCE unterstützt Sie in allen drei Aktionsbereichen mit Ende-zuEnde Unterstützung. In Recherche von Richtlinien, Verordnungen und Normen. Ebenso wie der Erstellung der Produktanalyse, Risikobeurteilung, möglichen Messungen von Testlaboren, Kommunikation mit benannten Stellen etc.
Als Hersteller sind Sie in vielfältiger Art und Weise vom Thema CE betroffen.
- Sie stellen CE-kennzeichnungspflichtige Produkte her.
- Sie nutzen für die Produktion CE-kennzeichnungspflichtige Maschinen und Betriebsmittel.
- Sie kaufen CE-kennzeichnungspflichtige Bauteile ein, die in Ihren Produkten aufgehen.
easyCE unterstützt Sie in allen drei Aktionsbereichen mit Ende-zuEnde Unterstützung. In Recherche von Richtlinien, Verordnungen und Normen. Ebenso wie der Erstellung der Produktanalyse, Risikobeurteilung, möglichen Messungen von Testlaboren, Kommunikation mit benannten Stellen etc.
Als Hersteller sind Sie in vielfältiger Art und Weise vom Thema CE betroffen.
- Sie stellen CE-kennzeichnungspflichtige Produkte her.
- Sie nutzen für die Produktion CE-kennzeichnungspflichtige Maschinen und Betriebsmittel.
- Sie kaufen CE-kennzeichnungspflichtige Bauteile ein, die in Ihren Produkten aufgehen.
easyCE unterstützt Sie in allen drei Aktionsbereichen mit Ende-zuEnde Unterstützung. In Recherche von Richtlinien, Verordnungen und Normen. Ebenso wie der Erstellung der Produktanalyse, Risikobeurteilung, möglichen Messungen von Testlaboren, Kommunikation mit benannten Stellen etc.
Als Hersteller sind Sie in vielfältiger Art und Weise vom Thema CE betroffen.
- Sie stellen CE-kennzeichnungspflichtige Produkte her.
- Sie nutzen für die Produktion CE-kennzeichnungspflichtige Maschinen und Betriebsmittel.
- Sie kaufen CE-kennzeichnungspflichtige Bauteile ein, die in Ihren Produkten aufgehen.
easyCE unterstützt Sie in allen drei Aktionsbereichen mit Ende-zuEnde Unterstützung. In Recherche von Richtlinien, Verordnungen und Normen. Ebenso wie der Erstellung der Produktanalyse, Risikobeurteilung, möglichen Messungen von Testlaboren, Kommunikation mit benannten Stellen etc.
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Special features of conformity assessment and CE labelling of medical devices
Medical devices are categorised into three risk classes. Requirements are regulated in 2 ordinances:
- Medical devices are generally categorised into three risk classes according to their intended use (categorisation is carried out by the manufacturer): Class 1 are non-invasive, non-sterile medical devices that do not have a measuring function. Here, conformity assessment procedures and CE labelling are carried out by the manufacturer, with special preparation in accordance with specific medical device standards. easyCE can support you with this.
- For medical devices of the Class 2 and 3 certification by a "Notified Body", such as TÜV, DEKRA or MEDCERT, is required.
- Software can also be a medical device and fall under the CE labelling requirement. For example, clinical information systems, clinical decision support systems and smartphone apps. Please contact us to find out more.
From 26 May 2021, the requirements of the new Medical Devices Regulation (EU 2017/745) and the In Vitro Diagnostics Regulation (EU 2017/746), which replace the Medical Devices Directive (93/42/EEC), the Active Implants Directive (90/385/EEC) and the In Vitro Diagnostics Directive (98/79/EC), will apply. Due to the coronavirus pandemic, this deadline has been postponed by one year to 26 May 2021. There is then no grandfathering and all medical devices must be tested and certified in accordance with the new requirements.
REFERENCE PROJECTS
Conformity assessment, CE labelling and instructions for use for a permeate treatment system.
easyCE supports the entire conformity assessment procedure including the instructions for use for a permeate treatment system, i.e. the treatment of water as a preliminary stage for 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 provides support in researching 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, as well as materials such as titanium, had to be determined.
Support for the CE marking of horn eyeglass frames (Class I medical product) and sunglasses.
In a demanding project, easyCE has ensured the conformity of horn eyeglass frames as accessories to medical devices in accordance with the Medical Device Regulation 2017/745 and of sunglasses in accordance with the Personal Protective Equipment Regulation 2016/425. In this process, we expanded the technical documentation to ensure that all necessary documents such as the risk management plan and the post-market surveillance plan are included.
Our team has worked closely with the client to ensure that all requirements of the Medical Device Regulation are met, including the general safety and performance requirements according to Annex I. This included a thorough review of design and manufacturing requirements to ensure that the products meet the highest standards.
Furthermore, we've assisted the client in registration in relevant systems to obtain necessary identifications such as SRN (via EUDAMED), DMIDS (via BfArM) and UDI-DI (via IFA). Our expertise and commitment have enabled the customer to enter the European market seamlessly and streamline their conformity processes.
APPLIED, RELEVANT LEGAL REGULATIONS: Medical products 2017/745,
PPE-Directive 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
CBD-Lubricant | Hempartis GmbH | Sep – Jan 2022
CE Marking for a lubricant according to the medical products directive
Is my product a medical device? And if so, what class is it classified in? With the help of Directive 93/42/EEC on medical devices, easyCE finds the relevant requirements even in this case where definitions are ambiguous, informs the customer about his obligations and creates the necessary CE documentation around the existing quality management system. A risk management plan, checklists for technical documents, hazard identification and safety-relevant features, general safety and performance requirements according to MDR Annex I as well as a declaration of conformity are created product-specifically in German and English.
Drug test | Paramedi | Dec 22 – Mar 23
Sometimes it is not clear whether a product requires CE marking. In this particular case of a multi-drug test, the decision depends on the user group. While a drug test for criminal prosecution 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 product of
Class C. For this project, easyCE adapts the schedule particularly flexibly to the customer, 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 occur to the product. 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 in order to obtain SRN and basic UDI-DI.
Directive (EU) 2017/745
Directive (EU) 2017/746
Other perefence projects:
FAQ
According to which directives must medical devices bear a CE mark?
The conformity assessment and CE marking of medical devices is still regulated throughout Europe by three directives until 26 May 2021. These are as follows:
Is there grandfathering for medical devices whose conformity and CE labelling were carried out in accordance with the previous directives?
No, there is no grandfathering and all medical devices must be tested and certified in accordance with the new requirements.
Which types of medical devices must bear the CE marking?
Medical devices are categorised into three risk classes according to their intended use:
Do software and apps for use in the medical sector also require CE labelling?
Yes, software can also be a medical device and require CE labelling. For example, hospital information systems, clinical decision support systems and smartphone apps may fall within the scope of the above-mentioned directives and require a conformity assessment. Please contact us to find out more.
As a manufacturer of medical devices, what do I have to take into account for conformity assessment and CE labelling?
easyCE will be happy to help you identify the directives and standards that apply to your specific product. The next step of product analysis and we will be happy to help you with your risk assessment.
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