MDR and CE Marking
The EU's Medical Device Regulation (MDR) is the new requirement for European compliance. The QNR team can assist from start to finish: Strategy, planning and execution of technical documentation updates, and supporting notified body review and approval.
MDR and CE Marking
Medical Device Regulation (MDR) Remediation and Compliance - CE Marking for the European Union
The QNR team has provided years of leadership oversight as well as functional day to day support for the newly published EU Medical Device Regulation (MDR) (2017/745). Since its 2017 publication date, the team has years of experience actively remediating EU technical documentation and working with EU third party reviewers.
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A QNR consultant can guide your business through the steps to MDR compliance, provide both oversight and/or functional support, and deliver an MDR compliant file, including but not limited to the following items:
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Technical document with MDR compliant content;
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MDR classification;
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General Safety and Performance Requirements (GSPR) checklists;
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MDR compliant standards listings.
CE Marking for
European Compliance
QNR Support - The Complete Lifecycle
The QNR team has many years experience working with devices of all EU classes (Class I sterile, Class I measuring function, Class IIa, Class IIb, Class III) in support of the entire device lifecycle, and can support your business throughout your project.
Some additional support areas with respect to CE marking include the following:
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Technical documentation creation and maintenance (including Class I self-declared technical files through Class III dossiers);
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Planning, preparation, and submission of technical documentation to Notified Bodies, and working with the reviewers until approval;
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CE certificate issuance and renewal support.
Our QNR consultants have worked with various EU Notified Bodies (the entities responsible for routine reviews/approvals on behalf of the EU agencies) and EU Competent authorities (the EU agencies themselves) in support of the entire device life cycle, with many approvals and successes over the years. Customized solutions to meet your business needs are available to ensure your success.