Expert QA & RA Consulting for Medical Device Software
Welcome to our FAQ section. Here, you’ll find answers to the most commonly asked questions. For more detailed information, we invite you to explore our Knowledge Base. If your question remains unanswered, please don’t hesitate to contact us.
That depends if you ask the US or EU regulators.
The FDA uses the following definition of a medical device:
A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is—
Under EU-MDR the definition is as follows:
(1) ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
That depends on which market you are focusing on! At MedQR we are experienced to help you walk different paths. The 2 biggest western markets are the EU and the US. For US market access you need FDA clearance. For EU market access you have to obtain a CE mark.
Under FDA regulations you might need to go for a 510(k) or PMA submission.
What is a premarket notification (510(k)) submission?
A premarket notification, or 510(k), is submitted to FDA before a manufacturer proposes to market a medical device. If FDA agrees the new device is substantially equivalent to a legally marketed device for which premarket approval is not required, the manufacturer may market it immediately. FDA does not require clinical data in most 510(k)s. However, if clinical data are necessary to demonstrate substantial equivalence, the clinical study must comply with the IDE, IRB, and human subject protection (informed consent and additional safeguards for children in research) regulations. See section 520(g) of the act and 21 CFR Parts 812, 56 and 50. 5.
What is a premarket approval (PMA) application?
A premarket approval (PMA) application is the most stringent type of device marketing application for medical devices. FDA approves a PMA if it determines that the application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use(s).
What is CE-marking?
The CE mark for medical devices signifies that a device complies with European Union (EU) Medical Device Regulation (MDR), ensuring it’s safe, meets specific performance requirements, and can be legally sold within the EU. It’s a mandatory marking for most medical devices intended for the EU market, indicating the device has undergone a conformity assessment.
Complex? Yes it is! Under these regulations multiple guidance’s and ISO standards are applicable as well. Our MedQR consultants are ready and pleased to guide you through the maze.
EU rules on the safety and performance of medical devices were created in the 1990s. In April 2017, the European Parliament and the Council adopted Regulation (EU) 2017/745 and Regulation (EU) 2017/746 to reinforce the regulatory framework for medical devices and in vitro diagnostic medical devices.
The objectives are to achieve a high level of protection of health for patients and users of medical devices and in vitro diagnostics. And to ensure the smooth functioning of the internal market for medical device products. To achieve these objectives, and in light of issues identified with the previous regulatory framework, the Regulations set out a more robust system of conformity assessment to ensure the quality, safety, and performance of devices placed on the EU market.
The Medical Devices Regulation entered into force in May 2017 and became applicable on 26 May 2021. The transition period provided for in the Regulation will end on 26 May 2024. An additional ‘sell-off’ provision allows for the further making available until May 2025 of medical devices which are placed on the market before or during the transition period and which are still in the supply chain when the transition period has ended.
Unlike medicinal products, medical devices, including in vitro diagnostic medical devices, are not subject to a pre-market authorisation by a regulatory authority. Instead, medium and high-risk devices are subject to a conformity assessment procedure involving an independent third party known as a ‘notified body’.
Notified bodies are designated and monitored by the Member States and act under the control of the national authorities. Since 2013, assessments of notified bodies are performed by a joint team of members from other Member States and the Commission. Under the new framework, the successful experience of these joint assessments for the designation of notified bodies is reinforced.
Interaction with notified bodies runs more efficient if you speak their language. MedQR consultants are very experienced in notified body interactions and speaking the regulatory language. Easily understanding notified body feedback and reading between the lines of feedback.
Finding experience regulatory and quality personnel for your company can be challenging in an industry in which the request for experience is much higher then the availability. Letting a MedQR consultant fill in your regulatory affairs manager or quality assurance manager role on an interim basis can be an efficient way to overcome a short-term period, finding your own staff.
Alternatively, maybe you have sufficient staff, but their workload is (temporarily) to high, you are facing a maternity leave period within your team, or the experience/knowledge of your team is not yet at a sufficient level for full scope regulatory compliance of the full portfolio. Then MedQR consultants can support and in parallel, train your team to become future proof.
Also in case of a specific question, verifying your strategy, or a need for training, MedQR is able to help.
Yes of course! Our first contacts are always without obligations, we always offer a first free 30 minutes of consulting to provide you some feedback regarding the issues you might face. A good connection is important to establish any relationship/collaboration. So please feel free to contact!
A trusted consulting partner specializing in Quality Assurance (QA) and Regulatory Affairs (RA) for medical devices.
