WHAT IS CE MARKING?
CE stands for Conformité Européenne, which translates from French to English as ‘European Conformity.CE Mark Certification indicates that a product has been assessed by the manufacturer and deemed to meet EU(European Union’s) safety health and environmental protection requirements. CE mark mandatory conformity marking for regulating the products sold within the European Economic Area (EEA) since 1985. It is needed for products manufactured anywhere inside the world that is then marketed inside the EU(European Union’s).
CE Marking Strategy for Medical Devices?
To sell medical devices inside the European Union (EU), you must get or apply CE Marking to your product. As a Medical Device Software manufacturer, no matter whether you outsource the producing technique, you are responsible for acquiring the CE marking. In popular, the path towards acquiring the CE marking depends on the medical device’s class. Since in the light of the EU, MDR Medical Device Software is taken into consideration as an active medical device, it belongs at least to magnificence IIa MDR Medical Device Software is taken into consideration as an active medical device, it belongs at least to magnificence IIa.
What products need the CE Marking?
No. CE marking is compulsory for the greatest products protected by using the New Approach Directives. The process of establishing whether or no longer a product requires CE Marking is particularly complicated. Manufacturers want to set up.CE marking shows that the product meets sure statutory requirements connected with things like safety, health, and the environment.
The following products need CE marking:
- Medical devices
- Active implantable medical devices
- In vitro diagnostic medical devices
- Construction products
- Machinery
- Electronic equipment
- Personal protective equipment
- Pressure equipment
- Simple pressure vessels
- Gas appliances
- Radio and Telecommunications terminal equipment
- Lifts
- Cableways
- Equipment and protective systems for use in explosive atmospheres
- Explosives for civil use
- New hot water boilers
- Measuring Equipment
- Non-automatic weighing instruments
- Toys
- Recreational craft
The following product categories do not require CE Marking;
- Cosmetics
- Foodstuffs
- Chemicals
- Pharmaceuticals
How to Get CE Mark Certification?
First, we identify what directives are applied. this may include;
- Electromagnetic Compatibility
- Radio Equipment
- Low Voltage Directives
- CE Marking requires EMC checking for electronic and electrical products,
Steps in CE Marking;
- Decisions whether a product is a medical device and by which of the European medical devices directives it is covered.
- Identify the applicable harmonized standards.
- Classification of the devices by the manufacturer.
- Contact to Notified Bodies, Preliminary discussions, and exchange of information, choice of the notified body.
- Answering specific questions of the chosen notified body, confirmation of device classification bt the notified body, time and cost estimation for different certification routes; choice of the certification route by the manufacturer.
- Formal application and certification contract.
- Submission and Evaluation of documents to the notified body.
Audit of the manufactures’ operations and if applicable and required also suppliers and/or subcontractors’ facilities including reporting D. - The decision about the certification and issuing of the relevant certificate(s), which are usually valid for five years.
- Surveillance audits.
- Full re-audit and issuing of new certificates normally after five years.
We will manual you in Six Steps towards the successful Certification of your product.
Your intention is to finish the Certification process and affix the CE marking to your product. Thus, what you want is a clear outline of the necessary steps and the most qualified professionals by using your side. Depending on the product category, the course of action for acquiring a CE certificate varies. Yet, the basic process follows these steps:
- Check which EU Directives apply for your product.
- Search for essential requirements for your product.
- Determine if the product requires Notified Body evaluation.
- Assess product conformity.
- Draft and maintain technical files.
- Draw up the Declaration of Conformity and affix the CE marking in all products.
