EU(CE) - Wiselink Group-A More Controllable, Stable, and Future-Oriented Material Direction

EU Medical Device Regulatory Authorities

The European Union consists of 27 member states. The key entities involved in the review and regulation of medical device registration include: the Ministry of Public Health, the Medical Device Coordination Group, third-party certification bodies (Notified Bodies, or NBs), and national competent authorities.

Among these, Notified Bodies (NBs) are the key technical entities responsible for implementing market access management in the EU. They are tasked with verifying whether products comply with EU directives and ensuring product safety and quality.

Regulatory Agency website link: https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng

Database link:https://ec.europa.eu/tools/eudamed/#/screen/search-device

Regulatory Framework

The key EU regulatory acts governing medical devices and their implementation dates are as follows:

1. Medical Devices Regulation (EU) 2017/745, applicable from 26 May 2021;

2. In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, applicable from 26 May 2022;

3. Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023, which amends the transitional provisions of the above two Regulations and extends the transition period for the Medical Devices Regulation (MDR) in phases.

Risk Classification

The European Union classifies medical devices and in vitro diagnostic (IVD) devices into risk categories, ranging from low to high:

Medical device classification: Class I (including general Class I, sterilised Class Is, measuring Class Im, and reusable Class Ir), Class IIa, Class IIb and Class III, where Class I represents low risk and Class III represents high risk;

IVD classification: Class A, Class B, Class C and Class D.

Essential Entry Requirements

1. Possession of an ISO 13485 system certificate and annual audit report;

2. Appointment of a designated European Authorised Representative;

3. All medical devices must be registered in the EUDAMED database.

Registration Language

English.

Responsibilities of an EU Authorised Representative

① Market Access: Ensuring that products from non-EU manufacturers comply with EU regulations; assisting with the preparation of technical documentation and ensuring the compliance of labels and instructions for use; facilitating market access for products; and liaising with national regulatory authorities;

② Communication and Coordination: Acting as the point of contact between the manufacturer and European regulatory authorities; handling communications relating to product approval, registration and reporting; responding to enquiries from regulatory authorities and providing technical documentation;

③ Technical Documentation Management: Maintain product technical documentation within the European Union, overseeing the preparation, updating and maintenance of documents for inspection by regulatory authorities;

④ Product Surveillance: Assist manufacturers in complying with EU product surveillance requirements, monitor product safety and quality incidents, and assist in market surveillance and product recall activities;

⑤ Verification of Compliance: Verify whether the manufacturer has drafted the EU Declaration of Conformity and completed the appropriate conformity assessment procedures;

⑥ Document Retention: Retain copies of technical documentation, declarations of conformity and relevant certificates, and provide them as required by regulatory authorities;

⑦ Registration Obligations: Confirm that the manufacturer has completed the required information registration in the EUDAMED database;

⑧ Cooperation and Notification: Cooperate with regulatory authorities in carrying out preventive and corrective actions, and promptly provide feedback to the manufacturer regarding product complaints and regulatory authorities’ requests for sample testing;

⑨ Legal liability: If a non-EU manufacturer fails to fulfil its regulatory obligations, the authorised representative shall share the legal liability arising from defective devices with the manufacturer;

⑩ Termination of authorisation: In the event of a breach of obligations by the manufacturer, the authorised representative may terminate the authorisation and immediately notify the Member State in which it is established and the relevant certification bodies

Registration Process, Timelines and Official Fees

I. Registration Process

II. Registration Timelines (Based on Wiselink’s experience)

Class I Basic Devices: 3–7 days, subject to actual processing circumstances;
Class Im, Ir, Is, IIa, IIb and III Devices: Processing times vary considerably, typically ranging from 9 to 12 months; in exceptional cases, they may extend from several months to several years. Factors influencing this include: differences between Notified Bodies, product complexity, product risk classification, and the completeness of the supporting documentation in the registration dossier.

八、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.

Fill Form

Whether you need more information or wish to cooperate with us, we will guide you through every step of the regulatory process. Subscribe to our newsletter for the latest global regulatory updates.