CE marking of medical devices
and in-vitro diagnostics
In the area of CE marking, we cover a wide range of products under Regulation (EU) 2017/745 for medical devices (MDR) and Regulation (EU) 2017/746 for in-vitro diagnostics (IVDR).
Under the Regulations
(EU) 2017/745
(EU) 2017/746
CE MARKING
The European regulations on medical devices (MDR – Regulation (EU) 2017/745) and on in-vitro diagnostics (IVDR – Regulation (EU) 2017/746) define market access requirements for medical devices. The manufacturer is responsible for assessing and confirming fulfilment of the requirements. On this basis, he can declare conformity with the legal requirements, issue a declaration of conformity and may affix the CE mark as proof.
With the CE mark, the manufacturer documents that his products fulfil the full conformity with the legal requirements and that the prerequisites for placing the products on the market or putting them into operation on the European market have been met. The CE mark is therefore proof of the conformity of a medical device with the EU MDR and IVDR regulations. To prove this, the medical device manufacturer must establish a quality management system that ensures, among other things, the implementation of a risk management process (minimisation of risks) and a clinical evaluation (MDR) / performance evaluation (IVDR) for each product.
In the simplest case (Class I medical devices or Class A in-vitro diagnostics – products with a particularly low risk), this conformity assessment is carried out by the manufacturer on their own responsibility.
With increasing product risk (risk classes IIa, IIb and III or classes A steril, B, C and D), independent conformity assessment is not sufficient. The manufacturer must also involve a Notified Body in the conformity assessment procedure, who evaluates manufacturer’s results and monitors the manufacturer’s activities.
In the field of CE marking, we offer a wide range of products for the conformity assessment procedures of a wide variety of products under Regulation (EU) 2017/745 for medical devices (MDR) and Regulation (EU) 2017/746 for in vitro diagnostics (IVDR).
Contact
Contact us for more information on CE marking
(EU) 2017/745
Here you can find further information on product 2017/745 (MDR)
(EU) 2017/746
Here you can find further information on product 2017/746 (IVDR)
Requirements for CE marking
The aim of CE marking is to document compliance with the basic safety requirements of EU regulations.
This already starts in the product development stage, which must be carried out in accordance with a documented, controlled process. The manufacturer must establish technical documentation, taking into account the requirements of Annexes II and III of the MDR and IVDR. This contains a clear description of the intended purpose of the medical device, including the clinical application and target group as well as indications and contraindications. In any case, the processes for design (development), production and quality control must be described. If product-critical processes are carried out outside the direct control of the manufacturer, these outsourced processes must also be described.
For all products, risk management, including suitability for use and clinical evaluation or performance evaluation, must be planned, documented and evaluated as well as be available as part of the technical documentation. The planning and evaluation of post-market surveillance (PMS) must also be presented. In addition, further essential safety and performance requirements are defined, which – if applicable to the product – must be documented by the manufacturer. These include, for example, biological evaluation, electrical safety and EMC, software, stability, requirements for products with medicinal components, biological tissue or material products, as well as sterile products or reprocessing and reprocessability.
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FAQ
Which requirements must be verified in a conformity assessment procedure?
Medical devices must fulfil strict requirements as part of the conformity assessment procedure.
In the area of safety, these include
- Analysis, assessment and minimisation of risks and side effects
- Ensuring biological compatibility
- Ensuring mechanical, electrical and electromagnetic safety
- Review of possible product combinations
- Completeness and comprehensibility of the safety instructions and instructions for use
In the area of performance and benefits
- Clinical or diagnostic evaluation
- Compliance with the advertised product properties and specifications
- Ensuring the therapeutic or diagnostic benefits
- Guarantee of measurement reliabilitysowie
and monitoring of the manufacturer and the medical device over the entire product life cycle.
Who monitors compliance with the CE marking?
The implementation of the EU regulations on CE marking is monitored by national market surveillance authorities.
These are defined in each European member state. A special feature of the federal system in Germany is that, in addition to federal authorities, monitoring is the responsibility of the state authorities in particular.
In addition, manufacturers are monitored by notified bodies as part of the conformity assessment procedures with regard to the continuous maintenance of conformity.
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