Medical equipmentEntering the European market is not simply selling products. Only in-depth understanding and following the regulatory requirements of the European Union can ensure success. However, need to meet a range of regulatory requirements of the European Union. This article will provide you with detailed information about these processes and requirements.

The regulation of medical devices in the European market has undergone a shift from MDD to MDR. Unlike products for medical purposes only, MDR has expanded the scope of regulation to include a number of devices for non-medical purposes, such as color contact lenses and cosmetic products. In addition, reusable devices are classified as a category in the MDD, while in the MDR, conformity assessment is required by an advertising agency.

CE Technical Documentation is key to entering the EU market, here are the steps for preparing the CE Technical Documentation:

1) The collection of information:Enterprises need to prepare enterprise information, product instructions, test reports, product packaging labels, product post-marketing information and so on.
Preparation of technical documents:Technical documents are drawn up on the basis of the above information.
3 The evaluation:An internal review is carried out or submitted to a third-party certification body according to the product’s risk level.
Modification does not comply with:Changes are made based on review feedback.
Finally submitted:After the repair is completed, the company continues to review and finally deliver.

It is worth noting that unlike MDD, which allows many products to share a single technical documentation, MDR requires each product to have a separate CE technical documentation.

The European Authorized Representative is the legal representative of manufacturers outside the European Economic Area in Europe.Their primary responsibility is to ensure that manufacturers meet the regulatory requirements of Europe.The selection and registration process for the European Authorized Representative is as follows:

1) Fill out the application form:The EU delegates will collect customer product instructions, DOCs and other information.
Submission of registration information:The representative of the European Union shall submit the registration information to the competent authorities of the Member State of residence.
Receipt of approval results:After approval by the competent authority, the EU representative shall deliver the registration letter to the client.

In order to meet the requirements of international regulations, it is recommended that exported medical devices be imported to the ISO13485 standard.Overseas customers will often require medical device manufacturers and exporters to have ISO13485 certification, which is crucial for increasing the international competitiveness of enterprises.