Certification according to Medical Device Directive MDR (EU) 2017/745
Principles and Significance
Within the European Economic Area, medical devices have to be CE marked, before placed on the market. The CE- marked medical device must fulfil the essential requirements of the European Medical Device Regulation concerning safety and performance as documented in the framework of the conformity assessment procedures. These procedures and their implementation are laid down in the Medical Device Regulation (EU) 2017/745 and its Annexes. Depending on the risk classification of the product, conformity is either confirmed by the manufacturer in his own right, or by involving a Notified Body.
The type of the conformity assessment procedure and the extent to which an independent assessment and certification body (Notified Body) must be involved, depends on the potential risks associated with the product. While there is no further differentiation in the risk class of active, implantable medical devices, Annex VIII of Regulation (EU) 2017/745 provides a grouping of devices into 4 classes (I, IIa, IIb, III) and the applicable rules for classification.
Notified bodies carry out the related system assessments as well as product examinations and issue the corresponding certificates. DQS MED is a notified body of the European Union and as such authorised to perform conformity assessments according to Regulation (EU) 2017/745, which are mandatory for all Medical Devices, regardless if produced in or imported into the EU. We carry out conformity assessment procedures according to EU Regulation Annexes IX and XI/A and review the technical documentation for conformity to the requirements of the EU Regulation Annexes II and III.
Regulation (EU) 2017/745 - for which customers?
Before you place a medical device on the European market or put it into operation, your medical devices must be CE marked. A medical device describes an object or a substance used for medical, therapeutic or diagnostic purposes for human beings, whereby the intended main effect, in contrast to medicinal products, is not primarily pharmacological, metabolic or immuno- logical, but physical or physicochemical. CE marking is a legally binding statement by the manufacturer that his product meets all legal requirements of European union medical device regulations.
Benefits of a medical device CE-Certification
The CE-certification by DQS-MED enables you to further exploit potentials, both in developed markets as well as to enter new national and international markets with the associated assessments of the devices and the Quality Management System, conforming to regulations. The certification will not only give you a clear competitive edge, but will also help to mitigate Risks and reduce liability obligations.
The process starts with the client’s needs and expectations. DQS wants to learn about the client’s organization, its management system, size and types of operation. Together both parties will define objectives for the assessment and/or certification, including applicable standards and specifications.
DQS will provide a detailed offer for assessment and certification services, tailored to individual client needs, based on the information provided initially. A written contract will specify all relevant deliverables as well as applicable assessment and certification criteria.
A pre-audit can serve as initial performance or gap analysis, identifying strengths and areas for improvement. For larger assessment and certification projects a project planning meeting provides a valuable opportunity for the client to meet the lead assessor and develop a customized assessment plan for all functions and locations involved. Both services are optional.
The assessment procedure itself begins with review and evaluation of system documentation, goals, results of management review and internal audits. During this process, it will be determined whether the client’s management system is sufficiently developed and ready for certification. The assessor will explain findings and coordinate any required activities to prepare for the on-site system assessment.
The assigned auditor team will audit the client’s management system at the place of production or service delivery. Applying defined management system standards and specifications, the assessment team will evaluate the effectiveness of all functional areas as well as all management system processes, based upon observations, inspections, interviews, review of pertinent records, and other assessment techniques. The audit result, including all findings will be presented to the client during the closing meeting. Required action plans will be agreed upon as necessary.
The independent certification function of DQS will evaluate the audit process and its results, and decide independently about issuance of the certificate. The client receives an audit report, documenting the audit results. When all applicable requirements are fulfilled the client also receives the certificate.
Either semi-annually or at least once per year, there will be an on-site audit of the critical components of the management system. Improvement potential will be identified, with a focus on continual improvement and sustained effectiveness.
A management system certificate is valid for a limited period of time, frequently for a maximum of three years. At the end of this cycle, a re-audit will be carried out to ensure the ongoing fulfillment of all applicable requirements. Subject to this fulfillment, a new certificate will be issued.
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