What are the regulations related to CE marking? How to find?

For medical devices, there are three existing directives:

1. Medical Devices Directive MDD 93/42/EEC;

2. In Vitro Diagnostic Medical Devices Directive IVDD 98/79/EC

3. Active Implantable Medical Devices Directive AIMD 90/385/EEC Since 2020-5-26, the above MDD and The Active Implantable Medical Devices Directive AIMD 90/385/EEC Since 2020-5-26, the above MDD and AIMD Directives are invalidated, and the following regulation is mandatory: MDR Regulation 2017/745; Since 2022-5-26, the above IVDD Directive is invalidated, and the following regulation is mandatory: IVDR Regulation 2017/746 For personal protective products, the EU 2016/425 PPE Personal Protective Equipment Regulation applies.

These can be found on the official EU website.

1.EU Medical Devices Regulation MDR: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32017R0745

2.EU Medical Devices Regulation MDR Guide:

https://ec. europa.eu/growth/sectors/medical-devices/guidance_en#consensus

3. EU Personal Protective Equipment Regulation EU 2016/425:

https://ec.europa.eu/growth/ sectors/mechanical-engineering/personal-protective-equipment_en