MDR Certification:
The path to approval for your medical devices.
FAQ – frequently asked questions
How does MDR certification differ from the authorisation of medicinal products?
How does MDR certification differ from the authorisation of medicinal products?
In contrast to medicinal products, which are formally approved, the conformity assessment of medical devices is carried out by the (certified) manufacturer itself. They must prove that the product meets all the necessary requirements in order to receive a declaration of conformity and bear the CE mark.
What’s Medicoforum’s role regarding MDR certification?
What’s Medicoforum’s role regarding MDR certification?
Medicoforum provides medical device manufacturers with comprehensive support for MDR certification. We offer expertise and experience to accompany the entire conformity assessment process, including the establishment of a quality management system, the preparation of technical documentation including risk management and clinical and biological evaluations.
Why should I choose Medicoforum for MDR certification?
Why should I choose Medicoforum for MDR certification?
Medicoforum has extensive experience and expertise in the field of MDR certification. We not only provide up-to-date information and practical support, but also guide you through the entire process to ensure that your medical devices meet the required standards and are marketable in the European Economic Area.
How can I get in touch with Medicoforum?
How can I get in touch with Medicoforum?
For an initial consultation and further information on MDR certification, you can contact our specialists directly. We are at your side with help and advice to pave the way for the successful certification of your medical devices. Please use the contact form at the bottom of this page, send us an e-mail or give us a call!
New MDR certification requirements since 2021
The Medical Device Regulation (EU) 2017/745 (MDR) has served as the legal basis for MDR certification of medical devices throughout the EU since May 26, 2021; it is binding in all EU member states and does not need to be transposed into national law. In addition, there are national legislations in each member state, which can sometimes make marketability difficult.
We accompany you during your MDR certification
It should be noted at the outset that medical devices are not approved in the formal legal sense, as is the case with medicinal products, but are generally assessed for conformity by the certified medical device manufacturer itself. For this, the manufacturer must have gone through MDR certification, which we can assist you in achieving.
How we can help you with MDR certification:
For medical devices there are essential safety and performance requirements which must be met in a conformity assessment procedure. These regulations serve to ensure the safety of a product.
To this end, the manufacturer must establish a quality management system that, for example, performs risk management and clinical evaluations for each product.
MDR risk class classification
The risk class of the medical device is decisive for the degree of personal responsibility of the manufacturer. Within the scope of certification, the MDR distinguishes between four risk classes, which classify medical devices be means of defined criteria.
Risk class I:
The lowest risk class 1 allows the manufacturer to take complete responsibility of the testing and certification process. Within the scope of certification, the MDR distinguishes between four risk classes, which classify medical devices by means of defined criteria.
Risk classes IIa, IIb and III:
In the case of higher risk classes, a private-law and independent testing and certification body (notified body) must be involved in the medical device approval process. This, in turn, is subject to a European-organized, state designation procedure and the observation of the competent authority. The Notified Body is responsible for carrying out the prescribed tests and issuing the corresponding certificates.
Do you have questions about the classification of your product?
Talk to our specialists about an initial classification.
Every medical device must undergo the prescribed conformity procedure.
If a medical device meets all the necessary performance and safety requirements and can demonstrate the acceptability of the risk-benefit ratio, this is documented in a declaration of conformity and given the CE mark, which makes it freely marketable throughout the European Economic Area.
Post-marketing vigilance systems (continuous monitoring) are in place that can identify risks and allow further monitoring of the products.
How Medicoforum supports you
Medicoforum is experienced in achieving and maintaining marketability. We help you with advice and action as well as keeping you up to date with the latest information, so that you can continue to develop your product. We can also use our experience and expertise to support you during the approval process of your medical devices or MDR certification procedure.
