What is the CE marking?
Medical Devices are characterised by the CE marking, which indicates that they comply with the legislation established by the European Community and which allows their free circulation within the countries of the Union.
Depending on the type of medical device, one of the Directives established in the 1990s applies to it:
- Active Implantable Products, Directive 90/385/EEC (AIMD)
- Medical Devices, Directive 93/42/EEC (MDD)
- In Vitro Diagnostic Medical Devices, Directive 98/79/EC (IVDD)
May 2021 is the date of application of the 2 new Regulations that repeal these Directives and will therefore establish the new Regulatory Framework for medical devices:
- Medical Device Regulation (EU) 2017/745 (MDR)
- Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR)
A Regulation does not require transposition into the legislation of each Member State and, therefore, from the same date of application it is in force in each and every one of the countries that make up the European Union. This should avoid divergences depending on the country in which the device is marketed, and will therefore favour the patient, bearing in mind that the most important thing in these products, apart from their proven efficacy, is that they are safe for the user.
Conformity Assessment
Prior to CE marking of the medical device, an assessment for compliance with the Essential Requirements for Quality, Safety and Efficacy of the product must be carried out by a Notified Body.
Each Agency has an identifying number which appears next to the CE marking of the evaluated product.
Class I products that are neither sterile nor have a measuring function are exempted from this conformity assessment by an external body. In order to be marketed, it is sufficient that a self-certification is carried out by the legal manufacturer of the product assessing that all regulatory requirements are met.