Conformity assessment procedures for an EU approval
Almost all medical devices that are to be placed on the market for the first time in the European Economic Area (EEA) require a CE marking (apart from custom-made products). This affects normal medical devices as well as in-vitro diagnostics (IVD) and active implantable medical devices.
By the CE mark the manufacturer assures that his product meets the essential requirements.
The legal framework in Europe is made up of various directives that are transposed into law by the nation states, in Germany this is the Medical Devices Act.
The requirements are recorded in the guidelines:
- 93/42/EWG (MDD for medical devices)
- 90/385/EWG (AIMDD for active implantable medical devices)
- 98/79/EG (IVDD for in-vitro diagnostics)
We support you comprehensively with the approval of your product in the following areas:
- Determination of the risk class
- Identification of an appropriate approval strategy
- Evaluation of the applicable harmonized norms and standards
- Preparation of the technical documentation
- Implementation of an ISO 13485 quality management system and auditing
- Consultation for the accomplishment of the risk management according to ISO 14971
- Support in terms of the marking of medical devices
- Implementation of the clinical evaluation
- Consultation for the implementation of the clinical trial
- Selection and communication of the notified body
- Support in terms of market surveillance and support for the development of a vigilance system/ Position of the security officer
Starting with the idea until the finished declaration of conformity in all areas, our experts are happy to support you!
The successful approval of medical devices in the US can be a challenge. Senetics supports you by classifying your product, selecting the right approval strategy, and other essentials.
Registration and listing
All companies that aim at distributing their products in the US, need to register themselves and their manufacturing facilities. All products must be listed with the FDA.
senetics conducts registrations on your behalf and lists your products with the Food and Drug Administration (FDA).
Classification of medical devices
Proper classification of medical devices in the FDA's system can be a challenge. The correct class must be determined by using the FDA's database. Unlike medical device classification in Europe, there is no provision for the risk class using classification rules. In the US, this classification is made by the FDA. Therefore it is in particular difficult cases possible to obtain the Council from the FDA.
senetics assits you by classifying and, if necessary, by making a 513 (g) application to the FDA on your behalf.
FDA 510(k) Premarket Notification
In order to distribute a Class II medical device in the United States, the manufacturer must obtain a 510 (k) clearance from the FDA. The core of a 510 (k) is the evidence of substantive equivalence with another medical device already marketed in the United States. Substantial equivalence means that the new device is at least as safe and effective as the reference product.
senetics assists you by identifying the reference products, chooses together with you the appropriate 510 (k) Premarket notification and supports you by implemeting this.
FDA Premarket Approval (PMA)
The Premarket Approval (PMA) is the strictest form of approval of new medical devices in the US market. Due to the increased risk of Class III products, the FDA has determined that compliance with essential requirements is insufficient to ensure the safety and effectiveness of Class III products. Therefore, a Premarket approval (PMA) application under Section 515 of the FD & C Act must be submitted for these products. Unlike Premarket Notification (510 (k), safety and effectiveness in PMA approval is not achieved by direct comparison with reference products, but must be fully documented in clinical or laboratory tests.
senetics provides you with comprehensive support for the approval of your Class III product in the USA.
FDA Investigational Device Exemption (IDE)
An Investigation Device Exemption (IDE) is used to use an unapproved product within clinical trials to collect safety and effectiveness evidence. Clinical trials are usually performed to support a PMA.
senetics will develop the necessary documents and documents for the approval and execution of your clinical trial with you.