CE Marking Medical Devices (MDD)

CE Marking for Medical Devices and Sanitary Products (MDD)

European Regulation 2017/745/EU & Directive MDD 93/42/CEE

The European Regulation 2017/745/EU & Directive 93/42/EEC for Medical Devices and Sanitary Products harmonises the safety and health requirements for the design and manufacture of this type of products at European level and for the entire European Economic Area (EEA). These products must meet all the requirements established by law before being introduced to the market.

The aim of this directive is to guarantee safety and protection for the health of patients, users and others in relation to the use of health devices and sanitary products. As this is an extensive and critical field in public health, this regulation/directive needs to be harmonized in context with others, taking into account pharmaceutical and clinical aspects. 

By fixing the CE Mark on these products, the manufacturer or importer guarantees that they meet the requirements established by law in the European Union for the safety and health of patients.

Brief Regulation nº 2017/745/EU
- Modifications -
IMPORTANT: On the eve of the new Regulation (EU) 2017/745 for Sanitary Products and Medical Devices that will come into force on 05/26/2020, the current Directive 93/42/EEC will be repealed.

¿Need assessment to perform the CE Marking to Medical Devices or Sanitary Products?

Sherpa Product Certification provides effective assistance at any stage during the certification or CE Marking of Medical Devices & Sanitary Products and products covered by the European Regulation 2017/745. Our intervention will summarize and delimit the legal framework that applies to your products, facilitating the identification and understanding of requirements and the development of processes to fulfill them.

How Sherpa Product Certification can help?
  1. Classify the product and determine the legal framework applicable in each case. 
  2. Identify essential requirements in specific Directives by product.
  3. Identify, acquire, adapt to the design and carry out tests on products according to Harmonized European and Regulatory Standards. 
  4. Check and manage the intervention of an Accredited Body (Notified Body).
  5. Evaluate the Product’s Conformity Evaluation according to the mandate established in the Directive. 
  6. Prepare and maintain the technical documentation. 
  7. Write the Declaration of Conformity and carry out the CE Marking.
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How can we Help you?

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Sherpa Product Certification is formed by a group of engineers who are experts in regulation and standardization of products, materials and industrial processes at an international level. Our essence as Sherpas is to help our clients to create lasting value in their business and meet their professional needs. If you need help in the procedures of a certificate or simply need specific information about our services, we are  happy to help you. Hire a Sherpa in your company and forget about legislation and documentation of your products. Our Sherpas certification experts report quickly and efficiently to the needs of our clients when we are most needed.