CE Marking

The manufacturer certifies that their product complies with the General Safety and Performance Requirements of the applicable European Regulation by applying the CE Mark. Once a product has received the CE Marking, it can travel freely within the European Union and the European Free Trade Association (EFTA) (EU). Additionally, it means that non-conforming goods may be withdrawn by customs and other enforcement agencies.

EU 2017/ 745 – MDR CE Marking

EU 2017/ 745 Medical Device Regulation is the new regulation that makes its way after negotiations between the European Commission, European Parliament, and the European Council. New medical device regulation replaces the medical device Directives (93/42/EEC) and the Active Implantable Devices Directive (90/385/EEC).

The background work for the EU MDR by the European Commission dates back to 2012 when a plan to restructure the Regulatory Framework and revise the existing regulations was laid down. The new regulation was first read out in the Parliament in 2014, and the final text was available in June 2016. After the current translation works into the official European Languages, it is expected that the MDR will be available for application by May 2017.

The overall objective of the MDR CE Marking has been to ensure a high level of protection of human health and safety and to provide a framework that is Conducive to the Innovation and competitiveness of the European medical device market.

    • Increased accountability of European Authorized Representatives
    • Stringent Clinical Evaluation
    • More Technical Documentation Requirements
    • EUDAMED Database
    • Implementation of UID
    • New classification method

The definition of Medical Device CE Marking is provided in MDR 2017/745, Article 2. The following devices fall under the article 2 definition, for example:

    • General use medical devices (Sterile and Non-Sterile)
    • Active Medical Devices
    • Non-Active medical device
    • Implantable Medical Devices
    • Medical equipment and machinery
    • Home Healthcare Devices
    • Software as Medical Devices (SAMD)
    • Active Implantable Medical Devices

Before being sold in the European Economic Area, medical devices must be CE-marked. CE Marking verifies that your Medical Device has been evaluated by a

What is the process for obtaining CE Certification? What is the CE Marking Approval Process for MDR? What goes into a Technical File? The flow chart below answers many of the questions.

CE Marking Approval Process

EU 2017/ 745 Notified Body

EU 2017/ 745 Medical Device Notified Bodies are authorized to issue CE Certificate by verifying the submitted technical documentation to prove the safety and performance of the device and to check its compliance with EU safety, health, and environmental regulations. We consultants will create a technical file showing that your Medical Device / Medical Instruments / Medical Disposables / Medical Software / Medical Machinery / Home Health Care Devices meets all of the EU Medical Device Regulation (MDR) standards before applying the CE Marking. Following CE certification, the manufacturer/importer must establish the CE marking logo on the medical device. The CE Marking logo must be visible on both the primary and secondary packaging of the device.

MDR CE Marking Consultants

Over the last four years, we have spent a significant amount of time and money building our in-house consultant’s team of CE Marking to make MEDDEVICECORP the best CE Marking Consultancy service provider. By doing business remotely in the cloud, we can provide multidisciplinary insights into Risk Analysis, Biological Evaluation, Clinical Follow-up, and Clinical Evaluation whilst minimizing travel and lodging costs. We represent our global and local clients with the same intense emphasis on quality suitable for early CE Certification, thanks to our organization’s common, clear strategy and structure.

Before the final implementation of the EU MDR (2017/745), all of the necessary and inevitable improvements are unknown. This will prove to be a time-consuming and difficult process for all medical device manufacturers. As a result, it is recommended that you stay informed about upcoming changes and their implications for your system and obtain expert technical advice from the CE Marking Consulting team of MEDDEVICECORP for implementation and enforcement.

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