Company insight
Navigating medical device regulations
One of the biggest hurdles to the medical device market is negotiating the minefield of regulations. For those new to understanding the rules or attempting to enter multiple markets – and must therefore meet multiple sets of regulations – it can be a bureaucratic headache. Aaron Johnson, vice-president of marketing and customer strategy at Accumold, describes how this can be eased when working with a micro moulder with 30 years of regulatory.
another. What is a given, however, is that working with a micro moulding company that is aware of the regulatory environment and can work through demands during product development is vital for timely and cost-effective market introductions. A poor grasp of the issues will only add to the product introduction challenge.
M
There are many medical device companies that want to enter multiple markets. A typical priority for manufacturers is to take the most expedient route to market and, while several influences can come into play, the regulatory environment can be the biggest hurdle. FDA regulations are regularly updated in the US and in the EU, MDR was implemented in May 2021 to replace the previous MDD.
A class act
Manufacturers planning a regulatory strategy face several questions. What is the best route to take for different types of devices? Is there a way to strategically support both FDA and MDR without doubling up? As a result of the recent adoption of MDR, FDA and EU regulations are now much closer aligned than they were previously. However, there are a few key differences between the two. Section 510(k) is the FDA’s pathway to market for devices classified as class I (low risk) and class II (moderate risk). Manufacturers must prove their devices are substantially equivalent to a predicate on the market in order to qualify under this framework. The premarket approval (PMA) pathway is required for class III devices, along with substantial data to validate and support the device’s risk- benefit profile.
aking a medical device is one thing, navigating the plethora of medical device regulations is
By contrast, EU MDR has four device categories and five risk-based classifications. The categories are: non-invasive medical devices, invasive medical devices, active medical devices and special categories. The risk classifications are: class I devices, non- sterile or does not have a measuring function (low risk); sterile and measuring function (low/medium risk); class IIa (medium risk); class IIb (medium/high risk); and class III (high risk). To obtain approval of a medical device under MDR, the assigned risk classification determines the amount and depth of data required. Clinical studies and adverse events will also be considered in the classification. There are different testing requirements for each device class – whereas the FDA does not require clinical testing for class I and some class II devices.
Different markets require different rules
Though many regulatory requirements remain the same, there are some substantial differences between FDA and EU MDR definitions. According to 21 CFR-quality system regulations, the FDA regulations are divided into sections that specify regulations for each category of device. Safety and effectiveness of devices are common requirements, but companies must comply with the requirements based on their risk profile and route to market.
The definitions and details of EU MDR are much more comprehensive. MDR goes into great detail about economic operators’ responsibilities, as well as those of notified bodies who perform the MDR assessment function. Additionally, it has definitions that differ from FDA, including penalties, funding obligations and cooperation rules. Documentation requirements for launching a product are very similar for FDA
Medical Device Developments /
www.nsmedicaldevices.com
and EU MDR regulations. For example, documentation is required for most aspects of risk management, design and manufacturing. FDA and MDR require documentation on verification and validation activities, planning and architecture. For CE marking, notified bodies also require a design manufacturing report. A key difference is that EU MDR requires a clinical evaluation report (CER). Manufacturers gather data, as well as search results from vigilance databases to identify known risks and hazards associated with the device. Is it possible to support MDR and FDA with the same documentation? For the most part, EU MDR regulations are on par with FDA guidelines. They have similar risk requirements, along with several other key documents and data points. Beginning with the device classification is a good place to start. It is crucial to set up a QMS properly early on as this will speed up the submission and time to market. The similarities and differences between the US and EU markets are very important for medical device companies that wish to enter both markets. If customers simply do not have the experience or time, working with a micro moulder with regulatory understanding of both markets could be well worth it. Start with the regulatory strategy early in order to maximise the chances of success. Accumold has specialised in the art and science of micro moulding for more than 30 years. It constantly innovates its processes to respond to the industry’s miniaturisation demands. This, combined with its experience navigating the regulatory requirements for medical devices, ensures cost-effective and timely new product introductions. ●
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