Deprecated: trim(): Passing null to parameter #1 ($string) of type string is deprecated in /var/www/ce-marking.solutions/html/wp-content/plugins/elementor-pro/modules/custom-css/module.php on line 76
The legislative framework for the CE marking of medical devices was revised with the adoption of 2 new regulations by the Commission. These two regulations thus replace the current Directives.
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, the Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79 /EC and Commission Decision 2010/227/EU
The new requirements only take effect after a transition period. This period is 3 years after the entry into force of the Medical Devices Regulation (2020) and 5 years in the case of the in vitro Diagnostic Medical Devices Regulation (2022).
Main changes
The two new regulations introduce a number of improvements to medical devices and medical devices for in vitro diagnostics:
Improving the quality, safety and reliability of medical devices: The new rules will impose stricter controls on high-risk devices such as implants and will require consultation with a group of experts at the EU, before the device was introduced on the market. Controls on clinical trials, as well as on bodies that can approve the marketing of medical devices, will also be strengthened. The new rules will also cover some aesthetic products that were previously unregulated (eg non-corrective colored contact lenses). In addition, a new risk classification system in accordance with international guidelines will apply to in vitro diagnostic medical devices.
Enhancing Transparency of Information for Consumers: New regulations will ensure that critical information is easily found. For example, patients will receive an implant card with all essential information and a unique device identifier will be mandatory for each product so that it can be found in the new European database on medical devices (EUDAMED).
Strengthening market surveillance and surveillance: Once devices are available on the market, manufacturers will be obliged to collect performance data and there will be closer coordination between Member States in the field market surveillance.
The legislative framework for the CE marking of medical devices was revised with the adoption of 2 new regulations by the Commission. These two regulations thus replace the current Directives.
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, the Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79 /EC and Commission Decision 2010/227/EU
The new requirements only take effect after a transition period. This period is 3 years after the entry into force of the Medical Devices Regulation (2020) and 5 years in the case of the in vitro Diagnostic Medical Devices Regulation (2022).
Main changes
The two new regulations introduce a series of improvements those on medical devices and medical devices for in vitro diagnostics:
Improving the quality, safety and reliability of medical devices: The new rules will impose stricter controls on high-risk devices such as implants and will require consultation with a group of experts at the EU, before the device was introduced on the market. Controls on clinical trials, as well as on bodies that can approve the marketing of medical devices, will also be strengthened. The new rules will also cover some aesthetic products that were previously unregulated (eg non-corrective colored contact lenses). In addition, a new risk classification system in accordance with international guidelines will apply to in vitro diagnostic medical devices.
Enhancing Transparency of Information for Consumers: New regulations will ensure that critical information is easily found. For example, patients will receive an implant card with all essential information and a unique device identifier will be mandatory for each product so that it can be found in the new European database on medical devices (EUDAMED).
Strengthening market surveillance and surveillance: Once devices are available on the market, manufacturers will be obliged to collect performance data and there will be closer coordination between Member States in the field market surveillance.
