So you’re an inventor who wants to develop a medical device and use the invention in practice. You know the FDA regulates medical devices, but that’s about as far as your knowledge takes you.
The European Medical Device Regulation (MDR) replaced the Medical Device Directive (MDD) in May of 2017. However, many medical device development companies are still working to understand the key differences between these guiding documents. Fundamentally, the MDR differs from the MDD in terms of device classification. Companies looking to commercialize their products in Europe will need to be familiar with these updated classifications and update their internal manufacturing, testing, and commercialization procedures accordingly.
Adapting to The EU Medical Device Regulation (MDR)
Medical device companies hoping to bring their products to market in the EU will now have to comply with the Medical Device Regulation (MDR), an update from the old Medical Device Directive (MDD). Companies that were already compliant with the MDD will need to pay close attention to this updated regulation, which departs from the MDD in several key ways.
Medical Device Material Selection: Pros and Cons Medical Device Companies Need to Know
Material selection is one of the most challenging—and important—components of medical device development. No matter how strong a concept or dedicated a team, selecting the wrong material can jeopardize a device’s commercialization timeline and likelihood of regulatory approval. Fortunately, the Kapstone team of experts is well-versed in device material selection and manufacturing as well as the testing needed to go with it. Our mission is to inspire, equip, and guide our partners in bringing the highest quality medical devices to market, which includes the material safety and effectiveness.
A Conversation With John Kapitan | Founder & CEO, Kapstone Medical
Medical device development companies large and small face different hurdles when bringing a new device to market. However, no matter their size, all companies cope with the inherent unpredictability of the development process—which, due to shifting regulatory guidance, the complexity of device manufacturing, and other factors, can quickly overwhelm timelines and budgets.
A Conversation With David Walsh | Director of Engineering
According to David Walsh, Director of Engineering at Kapstone, medical device companies really only have one goal: to “make sure their device is ultimately widely accepted in the market, easily understood, and can be used safely and effectively.” Sums it up, doesn’t it?
A Conversation With Justin Rowland | Project Manager
Bringing a medical device to market is difficult for startup and established medical device companies alike. Though the development and approval process can sometimes take years, those years are jam-packed with requirements and milestones that can challenge even the most experienced companies.
A Conversation with Kellen Hills | Regulatory Affairs Specialist, Kapstone Medical
Since 1906, the US Food and Drug Administration (more commonly known as the FDA) has protected consumers against the threat posed by adulterated, mislabeled, unsafe, or otherwise ineffective food and drug products. Regulatory affairs consultant Kellen Hills notes that before the FDA was empowered to regulate these products, “people were getting sick and dying because of unsavory characters putting things out on the market, making false claims about what they did with no oversight.”
Part 7 in a 7-part series on the EU’s Medical Device Regulation
The European Database for Medical Devices (EUDAMED) was conceived 20 years ago in 1998, originally as part of the In Vitro Diagnostics Devices Directive (IVDD) and included the Medical Devices Directive (MDD).
Under the new MDR that replaces the MDD, the European Commission recognized that to fully support the more stringent requirements for filing, reporting, and continuing surveillance, it would need to greatly expand the capabilities of the database for monitoring and data collection.
Part 6 in a 7-part series on the EU’s Medical Device Regulation
The new EU Medical Device Regulation (MDR) builds on the framework of the MDD with an increased emphasis on post-market surveillance (PMS) and post-market clinical follow-up (PMCF), similar to FDA’s approach for high risk devices.
Part 5 in a 7-part series on the EU’s Medical Device Regulation
Among the significant changes facing device makers transitioning their products in the European Union from the Medical Device Directives (MDD) to the Medical Device Regulation (MDR) are the new requirements around clinical evidence.
Under the MDR, device manufacturers marketing products in the EU will face some additional hurdles, but if you also market in the US, Canada, Japan, or other countries, the new regulations will likely be familiar to you.
Part 4 in our 7-part series on meeting the new requirements under the EU MDR
Complying with the European Union’s Medical Device Regulation (MDR) poses a daunting task for medical device makers marketing products inside the EU. One of the most taxing efforts for companies that already have CE-marked devices in the EU is the need for portfolio reviews.
Part 3 in our 7-part series on meeting the new requirements under the EU MDR
If you are new to obtaining marketing approval in the European Union, the concept of Notified Bodies is one of the most significant differences from the US FDA system or regulatory oversight.
A Notified Body is an independent certification organization that is “notified” by an EU member state’s Competent Authority, usually the ministry of health, to certify that a product meets the applicable requirements for CE marking.
Second in a 7-part series on the EU’s Medical Device Regulation
The new Medical Devices Regulation (2017/745/EU), or more commonly referred to as the EU MDR, poses significant challenges to medical device makers that want to market their products in the European Union.
The clock is already ticking and the three-year transition period is counting down to 26 May 2020, which is the “Date of Application” (DoA) of the Regulation.
First in a 7-part series on the EU’s Medical Device Regulation
The European Parliament passed the Medical Device Regulation (MDR) two years ago and began a three-year transition period in May 2017 with enforcement set to begin in May 2020.
The new regulation repeals and replaces the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD), effectively pushing the reset button for medical device makers who sell products in Europe.
Artificial Intelligence and 3D Printing are making history in the medical device world. From AI manufacturing machines to the creation of 3D printed organs to more streamlined processes by the FDA to approve 3D medical devices. Here is a quick overview of what you missed:
From 3D printed light receptors for prosthetic vision devices to $10 3D ultrasound chips and 3D printing for spinal cord injuries to 3D printed model body parts, a lot went on in the month of December. Here is a quick overview of what you missed:
Lots went on in the 3D Printing field last month. From 3D printed light receptors for prosthetic vision devices to $10 3D ultrasound chips and 3D printing for spinal cord injuries to 3D printed model body parts, a lot went on in the month of November. Here is a quick overview of what you missed: