Specific requirements for implantable medical devices pertain to the source of clinical data, the implementation of processes to ensure patient safety, and the provision of information regarding the safety and performance aspects of these devices.
Additionally, the conformity assessment procedure for implantable devices involves extra steps for a thorough verification of the clinical data supporting the manufacturer’s clinical evaluation report, compared to other types of devices. Even more rigorous regulatory requirements apply if the product is an active implantable medical device (AIMD).
We collaborate with you to create a robust compliance strategy tailored to your product, ensuring it meets MDR requirements and encompasses all aspects of quality, safety, and performance.
Our team identifies the relevant ISO and other standards that your implantable medical device must comply with, assisting in the integration of these requirements into the design and development process.
We support the development of your implantable medical devices by preparing all necessary documentation, including the implant card and Summary of Safety and Clinical Performance (SSCP), as well as registering in the EUDAMED database.
We provide regulatory guidance on planning and executing clinical investigations, along with performing clinical evaluations specifically for implantable devices.
We help navigate the conformity assessment procedure by offering support with documentation and interactions with Notified Bodies, ensuring a smooth and efficient certification process.
We handle implantable medical devices in multiple ways
What can we do for you
At Starodub, we offer specialized services tailored to assist in the development and regulatory compliance of implantable medical devices, including AIMD. Our comprehensive approach ensures that your products meet all necessary MDR requirements and are thoroughly prepared for the conformity assessment procedure.
Approach & Expertise
Learn how we can support you in meeting your business goals
- Our lean and powerful team with degrees in pharmacy, chemistry, biology, or related studies strive to be of added value to you. Our short reporting lines enable the most efficient road to your success.
- Having one point of contact from our experts backed by the team’s collective knowledge and resources we give reliable advice and execute projects seamlessly.
- At Starodub, consistency and assurance of quality are vital. A quality management system has been implemented and we adhere to GxP and ISO 9001/13485.
Questions from our clients
FAQ Section
According to Article 2(5) of the MDR, a medical device is classified as implantable if it is intended to be totally introduced into the human body, or to replace an epithelial surface or the surface of the eye by clinical intervention, and is intended to remain in place after the procedure, including those devices that are partially or wholly absorbed. The MDR also considers partially implanted devices as implantable if they are introduced into the human body by clinical intervention and are intended to remain in place after the procedure for at least 30 days. For example, an infusion port placed during surgery that remains in the body for at least 30 days is classified as an implantable device. Conversely, devices like a non-tunnelled central venous catheter, which is intended for temporary use and removal within 7 to 10 days, or a suture used for skin wound closure that is removed before 30 days, are not considered implantable devices.
One of the key requirements introduced by the MDR for implantable medical devices is the obligation for manufacturers to provide an implant card, as per Article 18. This card allows patients to easily access all relevant information about the implanted device, including identification and safety-related details through the EUDAMED database. Article 32 of the MDR mandates that, with the exception of custom-made devices, a SSCP must be prepared for all implantable devices. The SSCP provides public access to an updated summary of clinical data and other information about the safety and clinical performance of the device and shall be available to the public through EUDAMED.
To ensure a high level of safety and performance, compliance with the general safety and performance requirements for implantable devices must be demonstrated based on clinical data sourced from clinical investigations, although some exceptions exist. Manufacturers also have the option to consult an expert panel on their clinical development strategy before conducting the clinical evaluation and/or investigation, as outlined in MDR Article 61(2). Additionally, for Class III implantable devices, the conformity assessment procedure includes a thorough verification of the clinical data supporting the clinical evaluation report of the manufacturer. In this process the Notified Body prepares a clinical evaluation assessment report and an expert panel provides a scientific opinion, as specified in MDR Article 54 and Section 5.1 of Annex IX.
Clinical investigations under the MDR are not mandatory for implantable devices that have been lawfully placed on the market or put into service under Directive 90/385/EEC or Directive 93/42/EEC, as well as for specific types of devices, such as sutures, staples, and screws, for which the clinical evaluation is based on sufficient clinical data and is compliant with the relevant product-specific Common Specifications (CS), if such CS are available.
Furthermore, Article 61(4) of the MDR outlines exceptions to the requirement for premarket clinical investigations for implantable medical devices. These exceptions apply if the device is a modification of a previously marketed device by the same manufacturer, and the modified device is shown to be equivalent to a CE-marked device that was placed on the market under Directive 90/385/EEC or Directive 93/42/EEC, with sufficient clinical data already available. In such cases, although premarket clinical investigations may not be required, the manufacturer must include post-market studies in the Post-Market Clinical Follow-up (PMCF) plan to demonstrate the safety and performance of the device.