As we all know CE Marking stands for CE stands for Conformité Européenne (French), which means European conformity. CE Marking focuses on Health and Safety & Environmental protection standard. The CE mark is compulsory conformity marking for specific products traded in the European Economic Area (EEA) since 1985. The CE Marking gives you intelligence to sell your product in the EU, Norway, Iceland, and Liechtenstein. The CE marking wipes out your need for interest in many competing jurisdictional laws covering your products. CE marking converts another level of safety for customers and other end-users, which lower damage claims and insurance premiums.
You must obtain CE marking on your medical devices which will give you the right to sell your medical devices in European countries (EU), CE marking determines that your medical device fulfills with the appropriate EU organizations and allows the commercialization of your products in 32 European countries. As a legal medical device manufacturer, you are responsible for managing regulatory assent and guarding CE Marking for your product, although of whether you outsource any or all components of your manufacturing operation. A manufacturer is described as a person who is able to design and manufacturing a product with the intention of placing it in on the market under their personal name or brand. Even a person really manufactures, designs, packs, assembles, labels or processes a product themselves, or they authorize out any or all of certain duties, does not imply in concerns to CE marking. The manufacturer has the responsibility to assure that the product and design are made in agreement with the relevant act. They must also pick up the expected professional documentation and assure those relevant assessment methods are carried out.
CE Marking logo affixed on the medical device shows the device fulfills the quality specifications and coordinated standards. Medical Device Regulation EU MDR Regulation (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 are the two new regulations on the medical device.
Also, check ——>> CE marking certification in Sri Lanka
How to obtain CE marking for your medical device
CE is not a quality mark, but an understanding with EU Directives needs you to meet the appropriate standards of performance, quality, safety, and efficacy for your product type. However, the basic process follows these steps:
- Determine which EU Directive applies to your device: Medical Devices Directive (93/42/EEC), In Vitro Diagnostic Devices Directive (98/79/EC) or Active Implantable Medical Devices Directive (90/385/EEC).
- Determine the classification of your device. See our chart.
- Classify all the EU directives and standard for the product applicant of CE marking.
- Implement a Quality Management System, if applicable to your device. Most companies use ISO 13485 to meet the requirements.
- Prepare a CE Marking Technical File or a Design Dossier.
- Perform the conformity assessment according to relevant EU requirements of the directives.
- Prepare a Clinical Evaluation Report (CER) according to MEDDEV 2.7/1 rev4 and MDD (or MDR).
- Take necessary measures to make corrections of any divergence in the marking process.
- Select and appoint a European Authorized Representative to act on your behalf within the EU if you have no physical location in Europe.
- Attest the CE marking of the product.
- Have your QMS and Technical File/Design Dossier audited by a Notified Body unless your device is Class I, is not sterile and has no measuring function.
- Obtain CE Marking and ISO 13485 certificates from your Notified Body.
- Arrange all the required documents and certificates.
- Prepare and sign the EU declaration of Conformity.
- Prepare a Declaration of Conformity (DoC), which states that your device complies with the appropriate Directive.
Also, check ——>> CE marking consultant in Sri Lanka
To make the CE Marking Certification process simple. You should hire a consultant when a consultant received your application they will guide you and your business through the following steps.
- Gap analysis
- Formal assessment
- Internal Audit
- External Audit
- CE Marking Plan & how to get Certified
- Certification and beyond
NOTE: The process of the medical device will be changed when Europe’s new Medical Device Regulation (MDR 2017/745) comes into force in May 2020.