Notified Body (EU) Services

CE marking is the manufacturer's declaration that their product complies technically and administratively with the essential regulatory requirements of Medical Device Directive 93/42/EEC (MDD) and its supplementary Directive 2007/47/EEC, Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) and In Vitro Diagnostics Directive (IVDD) 98/79/EC, which outline the safety and performance requirements for active medical electrical equipment, non-active medical devices, and in vitro diagnostic medical devices. In order to place a medical device on the European market, manufacturer must obtain a CE mark.

STEMart can help you gain the certifications needed to bring your Medical Devices to the European market.

Key Elements of CE Marking

• Conformity Demonstration

Demonstrate conformity of medical device with safety and performance requirements specified in applicable directive and regulation.

• Classification Determination

Based on the intended use, characteristics and inherent risks of medical device, determine the classification according to Annex VIII of the Medical Device Regulation (MDR) 2017/745.

• Quality Management System

Implement a Quality Management System for all devices except Class I (non-sterile, non-measuring) according to Annex II or V of the MDD. ISO 13485 is used by most companies to meet requirements.

• Conformity Assessment Procedure

Based on the intended use, characteristics and risk class of medical device, determine a conformity assessment procedure.

• Technical Documentation or Design Dossier

Establish technical documentation or Design Dossier which covers the entire life cycle of product and clearly presents the characteristics and expected performance to demonstrate that the device conforms to regulatory safety and performance requirements.

• Clinical Evaluation Report

Prepare a Clinical Evaluation Report in accordance with MEDDEV 2.7/1 rev4 and MDD (or MDR).

• European Authorized Representative

Select and appoint a European Authorized Representative to act on your behalf within the EU if you don't have physical location in Europe.

• Selection of Notified Body

Select a Notified Body to audit QMS and Technical File or Design Dossier of medical device except Class I (non-sterile, non-measuring).

• CE Marking and ISO 13485 Certificates

Obtain CE marking and ISO 13485 certificates from Notified Body.

• Declaration of Conformity

Prepare a Declaration of Conformity to state the device complies with applicable Directive.

Notified Body Services

• Analyze information collected from manufacturer
• Help customer classify medical device
• Inspect technical documentation of MDDIs/Im, II a and II b and Self-Test IVD;
• Review and approve full Design Dossier of AIMD, Class III MDD and IVD Annex II List A & B devices;
• Carry out conformity assessments including any special procedures required;
• Issuing conformity certificates;
• Perform surveillance audits and control activities.

Why Choose Us

• In-depth knowledge of the laws & regulations;
• Experienced and efficient staff to lead the CE process;
• On-site assessments and testing;
• ATEX assessments and testing;
• Full CE documentation and support;
• Global regulatory compliance support beyond CE Marking.

STEMart provides superior Notified Body Service for medical device manufacturers to assist them earn a CE marking. If you want to learn more detail about our service, or would like to consult with the experts at STEMart, please feel free to contact us.