EU MEDICAL DEVICES REGULATION

Standard Introduction

In order to strengthen the pre-market and post-market management of medical devices, the European Union officially announced the MDR on May 2, 2017, and officially replaced the Medical Device Directive (93/42/EEC) on May 26, 2020, and The medical device manufacturer which sold the products to the EU must pay special attention to the validity period of the original MDD certificate.

• MDR announcement date: May 25, 2017

• MDR 3-year conversion expiration date: the impact of the epidemic is extended to May 26, 2021

• The validity period of the MDD certificate obtained after the MDR announcement date: The final validity period is May 26, 2024

Certificate Verification Benefit

Obtaining the MDR CE certificate can ensure that your company’s products continue to be legally sold in the EU.

Ensure that the medical devices sold under your company's name comply with laws and regulations, quality requirements, safety, and efficacy requirements and Significantly increase the chances of entering the international medical industry supply chain.

Applicable industry

Medical Device Manufacturers, Innovative Research and Development Companies, Final-End Product Manufacturers, Distributors/Sellers, etc., which is willing to become a manufacturer under the definition of EU Medical Device Regulation.

Training Course

• EU MDR requirements

• EU MDR Technical documents preparation

• ISO 14971 Medical Device Risk Management Requirements

• IEC 62304 Medical Device Software Life Cycle Management

• IEC 62366-1 Medical Device Usability Engineering

• MEDDEV 2.7.1 rev.4 Medical Devices Directives. Clinical Investigation.