Do you have a great idea for a medical device and need a partner to realize it and make sure it complies with the medical device regulation (MDR)? Is your development portfolio bigger than your R&D or quality and regulatory capacity? BAAT is your partner in expert medical device development. BAAT has the experience and know-how to transform your dream, idea, technology or problem into a product with manufacturing route, CE application and operations. All in line with the new medical device regulation.
What is the MDR meaning Medical Device Regulation?
All medical devices in the EU must bear the CE mark; it can be viewed as the ‘entry ticket to the EU market’. To get this mark on your medical device, it must meet the European regulations. Since 1993 this has been the Medical Device Directive (MDD), but a new MDR Medical Device Regulation (Regulation 2017/745 on medical devices) replaces that as of 26 May 2020. The MDR is more stringent than the MDD. There are updates in the risk classification of medical devices, requirements, increased oversight by notified bodies and more emphasis on clinical data and monitoring the device once it is on the market.
“Making your product a success is my biggest goal!”DymphyBusiness Developer | Baat Medical
Medical device classification MDR
The MDR defines several risk classes. Involvement from the authorities increases with higher risk products. The risk classification is based on 22 rules assessing several aspects that affect the risks associated with the device. For example invasiveness, duration of use and sterility. Each device falls into one of the following risk classes:
- Class I (low risk)
- Class Is: class I product that is delivered sterile
- Class Im: class I product with a measuring function
- Class Ir: class I product that is reprocessed or re-used – NEW
- Class IIa (medium risk)
- Class IIb (medium/high risk)
- Class III (high risk)
Compared to the MDD, the MDR has added new classification rules; most notably related to substances and software. It also introduces a new class for reusable Class I products: Class Ir.
General Safety and Performance Requirements
The MDR contains General Safety and Performance Requirements (GSPR) to which conformity must be shown. These requirements cover topics such as patient safety, biocompatibility, usability, labelling, and many more. The medical device regulation covers a wide range of devices; to suit the various devices, the requirements are often high-level. Following (harmonised) standards is the recommended way to show you meet these requirements.
Compared to the MDR’s Essential Requirements, the GSPR covers similar topics; some additional requirements are adopted from harmonised standards and there is more focus on risk and labelling.
Notified Body – Requirements
What is a notified body for medical devices? As manufacturer you must officially declare that your product conforms to the requirements from the MDR. For this, you must have technical documentation to support that your development process and resulting product to are conform the regulations.
For medium or high-risk medical devices, a Notified Body assess conformity before the device can be placed on the market.
When the device is on the market you must track the safety and performance and, depending on the classification, submit a summary at the notified body for review each year.
The MDR increases the notified bodies’ workload to get and keep medical devices on the market; the requirements and supervision on the notified bodies themselves have also increased.
Clinical data and monitoring
Medical device manufacturers’ responsibilities don’t end when the product reaches the market. You must keep an eye on the product for as long as it is on the market. The process of continuous tracking and regular re-confirmation that the medical device can continue to be marketed is Post Market Surveillance. Learn more about this process in Post Market Surveillance PMCF.
Contact us to get your medical device MDR compliant
When you transform your idea into an MDR compliant medical device, you will encounter hurdles. Contact us today to use our experience to navigate the intricacies of working with a notified body and get your product CE marked. As your full-service medical device company, we are partners for the complete journey and are only satisfied when your medical device is successfully treating patients.
Our Customers About Us
“Successful products are not made only of great ideas; they require a good understanding of todays and tomorrows market environment. The INNOVATE process was very insightful. It helped us define and decide what is necessary to fulfil all stakeholders’ present and future requirements in order to have a high impact product and treatment. BAAT did a great job!”Pablo EnriquezBelfry Medical GmbH
“Thanks to the close collaboration of our engineers with the BAAT team, we could execute our development strategy as planned. We couldn’t have reached this level of success without them.”Guntmar EisenEIT, a J&J company
“Baat heeft gezorgd dat mijn idee werkelijkheid is geworden. Het draagt nu echt bij aan betere zorg voor de patient, en aan het gemak van chirurgen. Geweldig om samen te werken aan het realiseren van een innovatie. Ik kan Baat 100% aanbevelen aan chirurgen en ziekenhuizen die echt stappen willen maken.”Ariaan D.P. van WalsumTrauma Chirurg, MST Enschede
“The engineering services of Baat really complements our own design process, while seamlessly integrating into our existing operations.”Dr. Hans-Joachim FischerWaldemar Link
“Thanks to everyone at Baat medical involved in this project. We are very satisfied with your service (including performance, communication, and flexibility) and are looking forward to possible new collaborations.”Dr. Oliver HassBSN Medical
“I would be happy to start another project in future and I’m looking forward to our further cooperation.”Katharina BarschSilony Medical