l What is a Legal Representative in EU clinical research

Driven by the globalization of medical devices, numerous high-end and high-risk medical devices manufactured in China are now targeting Europe. With the gradual shift from the transition period to the full implementation of the MDR and IVDR, the compliance standards for CE marking applications have become significantly more rigorous.

Regarding clinical evaluation, for high-risk devices falling under Class IIb and/or III, a growing number of Chinese manufacturers are establishing a presence to conduct clinical research in Europe. This strategy not only fulfills the compliance obligations set forth by the MDR but also facilitates seamless market entry into specific member states (e.g., Germany) post-CE certification.

01 Why is a Legal Representative required under EU regulations?

Pursuant to Article 62 of Chapter VI of Regulation (EU) 2017/745 (MDR)：

Where the sponsor of a clinical investigation is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative. Such legal representative shall be responsible for ensuring compliance with the sponsor's obligations pursuant to this Regulation, and shall be the addressee for all communications with the sponsor provided for in this Regulation. Any communication with that legal representative shall be deemed to be a communication with the sponsor.

02 What are the responsibilities of a Legal Representative under EU regulations?

Pursuant to Article 62 of Regulation (EU) 2017/745 (MDR), the main duties of the Legal Representative include:

--Ensuring compliance of the clinical investigation with the provisions of the MDR;

--Serving as the local channel for regulatory correspondence in the EU, including communication related to safety events;

--Notifying the Sponsor in the event of any identified instances of non-compliance;

--Managing other authorized tasks as agreed upon in the contractual arrangement with the Sponsor.

MDCG 2021-06 Rev.1 sets out the obligations of the Sponsor and the Legal Representative.

In order to enable the legal representative to ensure compliance with the sponsor’s obligations under the MDR it is recommended that a contract between the parties obliges - the sponsor to provide the legal representative with all required information and - the legal representative to immediately notify the sponsor in case (s)he becomes aware of any noncompliance with the Regulation.

03 What is the working mechanism of a Legal Representative

MDCG 2021-06 Rev.1 outlines guidance on the operational procedures, including the compliance assessment of technical documentation and clinical study documentation, the performance of audits during the clinical investigation process, and the audit of clinical investigation suppliers.

The legal representative is responsible for ensuring compliance with the sponsor’s obligations pursuant to the MDR. The MDR does not specify how a legal representative fulfils the legal obligations. 

The legal representative may perform audits of the sponsor and its subcontractor(s), or check compliance by other means, according to prior agreement. 

The legal representative would need permanent and integral availability and access to the technical documentation of the investigated device and clinical investigation documentation, in order to be able to ensure that this information has been drawn up and complies with the MDR. 

For the legal representative it would be necessary to be aware of specific aspects of the clinical investigation, i.e. not only to check the availability of procedures on a general level., in order to be able to ensure that the clinical investigation is compliant with the MDR in practice. 

It is necessary that the legal representative verifies, in parallel and/or in addition to the sponsor, all relevant documentation and keeps records of the verification activities performed. This verification is included in the legal representative’s responsibility for ensuring compliance with the sponsor's obligations pursuant to the MDR

In light of the Union's structure, conducting clinical investigations in Europe necessitates adherence to both EU MDR regulations and MDCG guidance, as well as territorial regulations of the respective Member States.

Additionally, since the EU's electronic system (UDAMED) is not yet fully operational or transparent, significant information gaps and grey areas remain.

Consequently, appointing a Legal Representative with profound expertise is essential to avoid potential pitfalls during the conduct of medical device clinical trials in Europe.

04 About Us

Care-Real provides medical device manufacturers with:

---Clinical Trials and Clinical Evaluation in China & Overseas;

---Multi-country Market Access and Regulatory Compliance Services.

Crealkraft GmbH and Qikraft UG are registered in Essen, Germany, holding a unique SRN (Single Registration Number). Our team possesses extensive regulatory and clinical research experience.Regarding our "EU Legal Representative" service, we offer:

1. Multi-dimensional Compliance ReviewWe conduct comprehensive compliance reviews of the CIP (Clinical Investigation Plan), IB (Investigator's Brochure), and ICF (Informed Consent Form). We have a robust document assessment system to verify the MDR compliance of key documents, as well as compliance with the specific requirements of individual Member States, particularly Germany and the Netherlands.

2. Systematic Clinical Investigation AuditsOur team includes highly experienced Auditors who perform audits during the conduct of clinical investigations to ensure sustained compliance with the MDR, GCP, and Ethical Committee (EC) requirements.

3. Local Handling of Safety IncidentsWe provide on-site/resident support for the management and processing of safety incidents.

4. Regulatory & Ethical CommunicationActing as the Sponsor's Representative, we manage all communications and interactions with Regulatory Authorities and Ethics Committees.