EU Regulation 2017/745, also known as the Medical Device Regulation (MDR), is a European Union regulation governing the approval of medical devices in the EU. EU Regulation 2017/745 covers all medical devices (except devices for in vitro diagnostics and products using gene, cell and tissue technologies), including implantable devices. The regulation replaces EU Directives 93/42/EC and 90/385/EC and came into force in 2017 and by May 26, 2021, all products on the European market must comply with the requirements set out in it. From this point on, EU Directives 93/42 and 90/385 will cease to have any effect. New products introduced to the market for the first time must immediately comply with the requirements of EU Regulation 2017/745.

ISO 13485 is a harmonized international standard for the development and implementation of Quality Management Systems (QMS) by manufacturers of medical devices. At the moment, the latest version of the standard is the 3rd edition of ISO 13485:2016. Bringing the QMS in line with the standard is highly recommended, since regulators in many countries prefer ISO-certified QMS. In some cases, manufacturers of low-risk products are an exception - they can use quality systems created according to the internal standards of companies. In particular, ISO 13485 certification is recommended for manufacturers seeking to sell products in the European Union. In the EU, ISO compliance is not a formal requirement, but a de facto manufacturer of medical devices without an ISO 13485 certificate in the EU has almost no chance of success. In addition, the requirements of EU Regulations 2017/745 (medical devices) and 2017/746 (in vitro diagnostic products) are harmonized with ISO 13485. Therefore, obtaining ISO 13485 certification for the EU market is a logical and appropriate step.

The CE marking is a mark of conformity that a manufacturer (as defined below) affixes to a product to enable it to be sold in Europe. This marking is mandatory for products that fall under one of the European directives (see table "Compulsory CE certification applies to the following product groups" below). The CE marking indicates that the manufacturer assumes responsibility for meeting all European Union (EU) health, safety, performance and environmental requirements that apply to its products. The abbreviation "CE" means "conformité européenne" (French) - "European conformity". This label is mandatory in the 27 EU member states as well as in Iceland, Norway and Liechtenstein. Switzerland uses the CE mark for some products, and even Turkey requires this mark to be on a large list of products.
Producer Definition - The natural or legal person responsible for designing, packaging and labeling a product for the purpose of placing it on the market on its own behalf.
Most importantly, the CE marking opens up access to the EU market of more than 500 million consumers.