EU MDR Regulation Services
The EU 黄人导航 Regulation (MDR) was published in the on May 5, 2017 and became the current regulatory standard on May 26, 2021. The EU MDR replaces the 黄人导航 Directive (MDD) [93/42/EEC] and the Active Implant 黄人导航s Directive (AIMD) [90/385/EEC].
The Transition Period began in 2017 for medical device manufacturers selling medical devices into Europe and continues today based on the medical device class for each regulatory submission. Regulatory Compliance 黄人导航庐 can assist clients that need to comply with the EU MDR requirements with the following services:
Transition to EU MDR Compliance
1. Perform a Comprehensive Review of Entire Product Portfolio and Current Certificate Expiry Dates
- Review and Assess the Client鈥檚 entire Product Portfolio including its:
- Legacy Products [CE marked devices under the 黄人导航 Directives (MDD) 93/42/EEC or the Active Implantable 黄人导航 Directive (AIMD) 90/385/EEC];
- Modified Legacy Products; and/or
- New Products currently in the Design/Development Phase.
- Confirm whether any Legacy Products and/or Modified Legacy Products have been affected by the new MDR Definitions and/or Reclassification of certain types of products into higher risk classes of devices;
- Reassess current classification of devices based on MDR Classification Rules;
- Prepare Product Rationalization Strategy Reports for Legacy Products, Modified Legacy Products, and New Products (as appropriate and applicable). which may assist the Client in making internal decisions about whether to maintain and/or bring such products in compliance with the MDR;
2. Staff Augmentation and Support
- Readiness Audits / Pre-Certification Audits and/or Assessments
3. Perform a Gap Assessment of the current Quality Management System (QMS) and its Current Processes and Procedures for MDR Compliance.
- Review and Assess the Quality Management System (QMS) requirements including all current policies, processes, and procedures against ISO 13485:2016 requirements
- Technical Documentation requirements
- Labeling requirements (including required languages in each Member States)
- Unique Device Identification (UDI) System
- Data entered into the EUDAMED Database per Article 33
- Risk Management System (RMS)听
- Risk Management Plan and Report for each device
- Clinical Data Requirements
- Data Integrity Best Practices
- Safety and Performance Requirements
- Post-Market Surveillance System (PMS)
- Vigilance Activities
- Market Surveillance Activities
- Requirements regarding Design and Manufacture of Devices per MDR requirements
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4. Remediation and Implementation of EU MDR Compliance Plan
- Supply Chain Requirements
- Development and Implementation of Compliance Plan for systems and devices
- Remediation of EU MDR Compliance Gaps noted during Assessment
- Development and听Implementation of EUDAMED Database compliance plan for all of the following six pillars of the EUDAMED
- Actor Registration
- Unique Device Identification
- Certificate
- Clinical Investigation
- Vigilance
Our broad range of 黄人导航 Regulatory Affairs consulting services include:
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To begin the Regulatory Compliance 黄人导航 scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.听You may also email us at [email protected].
