Chapter 1 Administration of European Union

1. Administration

The European Union consists of 27 member states. Organizations involved in the registration evaluation and supervision of medical devices mainly include: Public Health, Medical Device Coordination Group, the third-party verification agency (NB agency, Notify Body) and the competent authorities of various countries.

NB agency (Notify Body) ‌ is an important technical entity for EU to implement market access management in accordance with the new method directive. They are responsible for auditing and verifying whether the product meets the requirements of the EU directive to ensure product safety and quality.

2. Administrative Regulation

Medical Device Regulation（EU）2017/745, Applicable from 26 May 2021.

In vitro Diagnostic Medical Device Regulation（EU）2017/746, Applicable from 26 May 2022.

Regulation (EU)2023/607 of the European Parliament and of the Council developed at 15 March 2023, amending Regulations (EU)20171745 and (EU)20171746 are all concerning transitional provisions for certain medical devices and in vitro diagnostic medical devices. The Regulation extends in stages the transition period provided for in the Medical Device (MDR) Regulation (EU)20171745.

3. Risk Level Classification

Medical device classification: According to the risk level from low to high, it Is divided into: Class I (general Class 1 / Sterilized Is/ measured Im/ reused Ir), IIa, IIb and III, of which Class I (general Class 1 / sterilized Is/ measured Im/ reused Ir) is low risk, and Class III is high risk. 

4. Entry Requirements

ISO 13485 System certificate and annual audit report

European Authorized Representative

All medical devices need to be registered in the EUDAMED database

5. Registration Language

English.

6. Duties of representatives authorized by the European Union

① Market Access: Ensure that non-EU manufacturers' products comply with EU regulations, including technical document preparation, compliance of label and instruction, assist non-EU manufacturers to obtain market access, and communicate and negotiate with European national regulators to ensure the legal sale and distribution of products

② Communication and Coordination: Acting as the contact between the manufacturer and the European regulatory authorities, responsible for communication and coordination with the regulatory authorities on product approval, registration, reporting and other issues, answering the regulatory authorities' queries, providing the required technical documentation, and ensuring effective communication between the manufacturer and the regulatory authorities.

③ Technical Documentation Management: Responsible for maintaining the manufacturer's product technical documentation within Europe and ensuring that it complies with EU regulatory requirements, overseeing the preparation, updating and maintenance of the documentation for audit by regulatory authorities.

④ Product Supervision: Assist manufacturers in complying with EU product supervision requirements, including tracking incidents related to product safety and quality, assisting manufacturers with market surveillance and recall activities, and ensuring timely reporting and response to related issues.

⑤ Verification of Compliance: Verify that the manufacturer has drafted an EU Declaration of Conformity and that an appropriate compliance assessment procedure has been carried out.

⑥ Documentation Retention: Keep copies of technical documentation, declarations of conformity and relevant certificates and make them available to the regulator upon request.

⑦ Registration Obligation: Verify that the manufacturer has registered the required information in the EUDAMED database.

⑧ Cooperation and Notification: Cooperate with regulatory authorities for preventive and corrective actions and immediately notify manufacturers of complaints and requests for samples from regulatory authorities

⑨ Liability: If the manufacturer fails to comply with regulatory obligations and is not located in the EU, the authorized representative will be jointly liable with the manufacturer for any legal liability arising from the defective equipment.

⑩ Termination of authorization: In the event of a breach by the manufacturer of its obligations, the authorized representative shall terminate the authorization and immediately notify the Member State in which it is located and the relevant certification body.

These responsibilities ensure that medical device products from non-EU manufacturers can be legally sold on the EU market while complying with EU regulatory requirements.

Chapter 2 Registration Flow and Cycle

1. Registration Flow 

2. Cycle

Basic Class I products: 3-7 days based on Wiselink project experience, subject to actual conditions.

Im, Ir, Is, Ia, IIb, III products: a few months to a few years, generally 9-12 months, the factors affecting the cycle are as follows:

① The notified body is different

② The complexity of products is different

③ Product risk levels are different

④ Basic conditions of product registration documents are different

Chapter 3 FAQ

Q: Must clinical trials be conducted for medical devices or IVDs with IIa and above risk levels?

A: Not necessarily, according to the product characteristics and products has been approved by the market, most of the devices can be selected to meet the conditions of the substantial equivalent device for comparison.

Q: Do clinical trials have to be done in the EU?

A: There is no mandatory requirement, if there is no racial difference in the device, some notified bodies also accept domestic clinical reports in China, but the trial must meet the requirements of ISO 14155:2020 and other relevant guidelines or regulations. In vitro diagnostic reagents must meet the requirements of ISO 20916:2019 in addition to ISO 14155:2020.

Wiselink has clinical trial sites in Greece, Italy, Germany and Slovenia to carry out clinical trial projects for you.

Q: The product has obtained CE certificate. Can the label and instruction be in English when it is sold to EU member states?

A: Labels and instructions translated in the local official language are required, and are also required to be filed with the notified body in advance.