Personnel Protective Equipment (PPE) - CE Marking

Personnel Protective Equipment (PPE) - CE Marking

How we work on Personnel Protective Equipment (PPE) CE marking process? 

Step 1: Application to Notified Body

Step 2: Technical file preparation

Step 3: Shipment of Samples to Notified Body

Step 4: Testing of samples & Technical file assessment

Step 5: Resolving comments of Notified body & if test fails the test have to be conducted again & additional payment against that test have to be paid by you 

Step 6: If all testing went well then, the CE Certificate is issued.

We have more than 15 clients for Personnel Protective Equipment (PPE) consultancy, so we can exactly guide you to get through the certification at a quick pace.

What are the applicable standards for PPE CE marking? 

Product

Applicable Standard

N95 Respirator

EN 149

Coverall

EN 14126, EN 13034 & EN 13688

Surgical Gowns

EN 13795 & EN 14126


What are the benefits of CE marking? 

CE marking helps you to market your products in the countries of the European Economic Area (EEA). By implementing the requirements you may also find that your product is safer and more reliable; therefore reduce the risk of customer dissatisfaction. 

Moreover, due COVID-19 pandemic there is huge demand for Personnel Protective Equipment (PPE).

The timelines for certification under Personnel Protective Equipment (PPE) are as below: 

  • Normally we complete the Project within 90-120 days depending upon preparedness of Manufacture.


CE marking on a Medical Device proves that it meets the minimum legal requirements of the relevant Directive, which allows it to be placed legally on the market in any European member state. CE marking gives your company easier access into the European market to sell your products without adaptation or rechecking.   
Our team supports clients in meeting “European Regulatory Requirements” that declares the product offered is in compliance with “Essential Safety Requirements” / “General Performance and Safety Requirements” of relevant European safety, health and Environmental protecting regulation according to:  
- Regulation (EU) 2016/425 Personal protective equipment

What are EU Directives / Regulations? 

An EU Regulation is a form of legislation that sets out requirements your products must meet in order to sell them into Europe. 
The European Union introduced a series of measures to simplify the movement of goods throughout the European Union (EU) and the European Free Trade Area (EFTA). Some of these measures are known as New Approach Directives. New Approach Directives provide controls on product design and above all, seek to harmonize product safety requirements across Europe. 
The directives cover a very wide range of product areas including construction products, personal protective equipment and pressure equipment. Their primary objective is to ensure that the products are well designed, and safe for the user. 

Throughout Europe, where a New Approach Directive is in force, it is necessary for the manufacturer to CE mark their product. CE marking requirements vary from Directive to Directive, and even within Directives. 
Third-party testing, systems assessment and technical file assessments can be mandatory, but sometimes the manufacturer's claim is all that's asked for. But beware! If you claim your product complies and it doesn't, you will be prosecuted. Where a Directive requires products and/or systems to be independently tested, certified, or inspected, this must be done by a "Notified Body" or "Competent Body". 

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