EU service

The way to MDR certification

provided with our affiliate TS Quality & Engneering

We provide comprehensive proposal for successfully achieving MDR certification.

Our Team of seasoned experts can provide support in all the following activities and deliverables:

• Technical Documentation as per Annex I, II and III of MDR
• Risk management process as per ISO 14971
• Usability process as per IEC 62366
• Clinical Evaluation according to Meddev, MDCG and MDR
• PMS, PMCF, SSCP, PSUR
• Medical software as per IEC 62304
• Device master record
• Electronic IFU (e-IFU) smart solutions
• Medical device development
• MDSAP certification
• ISO 13485 certification and audit support
• IQ, OQ, PQ process validation
• Design control process remediation

• Person Responsible for Regulatory Compliance

• E-Learning
• Workshop onsite and remote

EU authorised representative

European Authorized Representative works as a connection between your company and the relevant national Competent Authorities (Ministries of Health) to ensure your compliance in Europe. Moreover, selected representative will make sure following:

• EUAR contributes with medical device registrations, as needed.
• EUAR address needs to be placed on the device labeling
• EUAR allows registration in EUDAMED of companies outside of Europe
• EUAR have to maintain an updated copy of concerned Technical File or CE Declaration of Conformity accessible for inspection by a Competent Authority, as needed.
• EUAR should support your company Vigilance activities with Incident and Field Safety Corrective Action (FSCA) reporting, in collaboration with the organization and its distributors

Swiss authorised representative

According to Swiss MedDo Article 51, the Swiss Authorized Representative should support Manufacturer in the following:

• Prove compliance with the registration obligations in Switzerland as per the revised MedDo.
• Prove compliance with MedDo’s device labeling requirements
• Giving access of the medical device’s samples to the Competent Authority.
• Cooperating with the Competent Authority to take any preventive or corrective action.
• Informing the manufacturer about complaints from patients, users, and healthcare professionals.
• Ensuring that Technical Documentation, EU Declaration of Conformity, and a relevant certificate is available for authority review
• Demonstrating device’s conformity by providing all the necessary documentation and information upon Competent Authority’s request.
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What can we do for You?

• ensures Swiss market access as your Authorized Representative
• offers to take the role as Person Responsible for Regulatory Compliance (PRRC) in Switzerland
• supports you in fulfilling labelling requirements and registration procedures for the Swiss market
• supports you in the handling of market feedback and your communication with CAs
• cooperates with your regulatory affairs consultant
• supports you to obtain the Swiss Unique Identification Number “CHRN”

UK responsible person

MHRA requires non-UK medical device manufacturers willing to market their devices in the UK to appoint a UK representative based in the UK.

Under MHRA, the UK REP has to serve the following roles:

• Ensuring the existence of the EU Declaration of Conformity (DOC) and technical documentation.

• Ensuring the availability of the documents as mentioned above and their certificates.

• Ensuring that the conformity assessment procedures are applied appropriately, and

• Cooperating with MHRA’s document requests.