Integrated Assessment Services (IAS) provides certification against EU MDR. EU MDR is the abbreviation for “European Union Medical Device Regulation”. EU MDR gives effect to Directive 2011/65/EU, which amends Directive 90/385/EEC on medical devices and introduces new regulatory requirements for medical devices. To identify the appropriate conformity assessment route please consult Annex VII of EU MDR. IAS will be able to provide certification against all routes.
What is the situation before EU MDR?
Before EU MDR, there was a large diversity of national rules in the Member States throughout Europe. In some countries, medical devices were regulated under medicinal legislation (Directive 2001/83/EC), while other devices were regulated as general-purpose machinery (Directive 2006/42/EC). For a device to be CE marked, it was necessary to follow both directives and undergo the relevant type-examination procedures.
What is the difference between EU MDR and national regulations?
The harmonization of medical devices under EU MDR means that medical devices are now subject to one single set of regulatory requirements. This means that a medical device type-examined in one Member State can be placed on the market anywhere within the EU. In addition, there will only be one route of conformity assessment (CE marking) and there is now only one entry point for regulatory requirements.
How does IAS support my conformity assessment activities under EU MDR?
IAS can provide independent and impartial advice on all aspects of conformity assessment activities for medical devices. IAS is not an assessment body or notified body, but we are able to provide technical support in the following routes:
- Internal Production Control (IPC), also known as ‘self-certification’ or ‘internal verification’;
- Authorized Representative;
- Qualified Person for Inspection and Testing (IQ);
- Quality System Assessment (QSA).
What are the advantages of IAS certification?
With its MRA and ISO13485 certification, IAS is already well-equipped to provide consultants in support of your conformity assessment activities. Our consultants have a wealth of experience in the medical device sector and this is complemented by our teams of qualified assessors. In addition to this, IAS has a network of assessment laboratories which enables us to offer certification against all routes within EU MDR.
How do I become certified?
IAS works in close partnership with you as your technical service provider. We support you from the early stages of development when you are negotiating a contract to purchase the appropriate assessment services to certification. We share your sense of urgency and we appreciate time is money in today’s business environment.
What do I have to present for certification?
You need to submit regulatory documentation, such as Risk Analysis (RA), etc., if available or all necessary documentation for the activities to be undertaken. This includes, but not restricted to:
- Quality Management System (QMS) documentation;
- Certification scope;
- Test reports and records from test laboratories;
- Appropriate procedures following certification.
What will I receive as a result of my certification against EU MDR?
You will receive the following:
- A certificate of conformity;
- A declaration of compliance.
What is the difference between a certificate and a declaration?
The CE marking consists of the last two digits of the year in which it was affixed (at least 11) followed by one or more letters. The first letter indicates the conformity assessment route: ‘a’ for IPC, ‘p’ for QP or ‘c’ for both routes. The second letter indicates the mode of CE marking: ‘e’ means the device is placed on the market under the user’s responsibility and ‘u’ means it is placed on the market under a distributor’s responsibility.
What happens if my products are defective?
If your product is defective, you should immediately withdraw it from the market. In this case, you must inform distributors and users of the withdrawal in writing and draw their attention to the risks associated with using the device and, if possible, also suggest a remedy.
The key requirement for notification to your Competent Authority (CA) on a CE marking and restrictions on the product is that it must be done without delay.
Where can I find out more information?
Further details can be obtained by contacting IAS at firstname.lastname@example.org.
We will also be speaking at the upcoming DASA seminar on March 14th where we will be discussing how to become notified or achieve other conformity assessment activities under EU MDR.
IAS is a Technical Service Provider (TSP) for medical device certification in India, South East Asia, West Asia, and Africa.
With MRA and ISO13485 certifications, IAS is well-equipped to provide consultants in support of your conformity assessment activities. We have a network of laboratories that enable us to offer certification against all routes under the EU MDR.
Our consultants are medical device experts with a wealth of experience within the industry. We work in close partnership with you from the early stages of development when negotiating a contract to purchasing appropriate assessment services right through to certification. We share your sense of urgency and appreciate that time is money in today’s business environment.
For more information, contact email@example.com .