Paragon provides EU MDR certification. The abbreviation of EU MDR is “European Union Medical Device Regulation”. The EU MDR affects Directive 2011/65/EU, which amends 90/385/EEC on medical devices and introduces new regulatory requirements for medical devices. Please refer to Annex VII of the EU MDR to identify the appropriate conformity assessment route.
What was the situation before the EU MDR?
Before the EU MDR, there was a great diversity of national laws in member states across Europe. In some countries, medical devices were regulated under medical legislation (Directive 2001/83/EC), while other devices were regulated as general purpose machinery (Directive 2006/42/EC). In order for a device to be CE marked, it was necessary to both comply with the directives and undergo the relevant type-examination procedure.
What is the conperision of EU MDR with the national regulations?
Harmonization of medical devices under the EU MDR means that medical devices are now subject to one set of regulatory requirements. This means that medical devices type-examined in one Member State can be placed on the market anywhere within the EU. In addition, there will be only one method of conformity assessment (CE marking) and now only one entry point for regulatory requirements.
How does the IAS support my conformity assessment activities under the EU MDR?
The IAS can provide independent and impartial advice on all aspects of conformity assessment activities for medical devices. IAS is not an assessment body or a notified body, but we are able to provide technical assistance in the following ways:
- Authorized representative
- Person Qualified for Inspection and Testing (IQ)
- Quality System Assessment (QSA).
What are the benefits of IAS certification?
Our consultants have extensive experience in the medical device sector and are complemented by our teams of qualified assessors. In addition, IAS has a network of assessment laboratories that enable us to offer certification against all routes within the EU MDR.
How do I become certified?
We support you from the initial stages of development when you are negotiating an agreement to purchase appropriate assessment services for certification. We share your sense of urgency and we value time in today’s business environment.
What do I need to submit for certification?
You need to submit regulatory documents, like Risk Analysis (RA) etc., if available or all required documents.
• Quality Management System (QMS) documentation.
• Scope of certification.
• Proper procedure after certification.
What will I get as a result of my certification against the EU MDR?
You will find the following:
- Certificate of Conformity.
- Declaration of Compliance.