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
1. This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union. This Regulation also applies to clinical investigations concerning such medical devices and accessories conducted in the Union.
2. This Regulation shall also apply, as from the date of application of common specifications adopted pursuant to Article 9, to the groups of products without an intended medical purpose that are listed in Annex XVI, taking into account the state of the art, and in particular existing harmonised standards for analogous devices with a medical purpose, based on similar technology. The common specifications for each of the groups of products listed in Annex XVI shall address, at least, application of risk management as set out in Annex I for the group of products in question and, where necessary, clinical evaluation regarding safety.
The necessary common specifications shall be adopted by 26 May 2020. They shall apply as from six months after the date of their entry into force or from 26 May 2020, whichever is the latest.
Notwithstanding Article 122, Member States’ measures regarding the qualification of the products covered by Annex XVI as medical devices pursuant to Directive 93/42/EEC shall remain valid until the date of application, as referred to in the first subparagraph, of the relevant common specifications for that group of products.
This Regulation also applies to clinical investigations conducted in the Union concerning the products referred to in the first subparagraph.
3. Devices with both a medical and a non-medical intended purpose shall fulfil cumulatively the requirements applicable to devices with an intended medical purpose and those applicable to devices without an intended medical purpose.
4. For the purposes of this Regulation, medical devices, accessories for medical devices, and products listed in Annex XVI to which this Regulation applies pursuant to paragraph 2 shall hereinafter be referred to as ‘devices’.
5. Where justified on account of the similarity between a device with an intended medical purpose placed on the market and a product without an intended medical purpose in respect of their characteristics and risks, the Commission is empowered to adopt delegated acts in accordance with Article 115 to amend the list in Annex XVI, by adding new groups of products, in order to protect the health and safety of users or other persons or other aspects of public health.
- 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?
- Classify the product and determine the legal framework applicable in each case.
- Identify essential requirements in specific Directives by product.
- Identify, acquire, adapt to the design and carry out tests on products according to Harmonized European and Regulatory Standards.
- Check and manage the intervention of an Accredited Body (Notified Body).
- Evaluate the Product’s Conformity Evaluation according to the mandate established in the Directive.
- Prepare and maintain the technical documentation.
- Write the Declaration of Conformity and carry out the CE Marking.
How can we Help you?
Contact your Sherpa
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.