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Multiple factors influence the length of time it takes for a new medical device to get to market, but the most critical is the time spent meeting regulatory demands.  

Medical device manufacturers will soon face a decision about whether to seek US Food and Drug Administration (FDA) approval or EU Medical Device Regulation (MDR) compliance. In the recent past, the differences were relatively stark and clear-cut – the EU’s Conformité Européenne (CE) mark was easier to obtain than FDA approval, but was a less powerful certification. FDA approval meant that the device was approved for use everywhere in the world, while the CE mark had restrictions even within the EU. But as of May 26, 2020, manufacturers will have to comply with the new European Medical Device Regulation (MDR) for general medical devices. Let’s look at 3 key areas where the new EU regulation differs from the FDA.

Definitions

FDA market authorization is based on Title 21-CFR Quality System Regulations, which are defined for each device category. According to the regulations, companies need to follow requisite regulatory steps assessing the overall risk profile for each device and ensuring reasonable safety and effectiveness – while adhering to the respective marketing pathways

The EU MDR is considerably more comprehensive, detailing the obligations of the economic operators, the revised CE marking process, the identification and traceability of the devices, and the registration of devices and their economic operators. It also lists the primary responsibilities and conditions for notified bodies, introduces post-market surveillance of marketed devices, details confidentiality and funding obligations, establishes penalties, tackles to topic of data protection, and lays out the rules for cooperation between member states.

Device Classifications

The first step in FDA submission is to identify the right class for the device using the FDA’s medical device databases. Class I and Class II devices (which have low and moderate risk) are regulated by the 510(k) notification, which requires product developers to present data demonstrating that the device functions similarly to a previously approved device. Devices with higher potential risks of illness or injury due to their application (implantable devices, for example) fall under the stricter premarket approval (PMA) notification. Under PMA, data demonstrating and validating the safety and effectiveness of a device needs to be presented, along with strict evaluations of benefits and risks.

The MDR, in contrast, has 4 categories of devices – non-invasive devices, invasive medical devices, active medical devices, and a special category that includes contraceptive, disinfectant, and radiological diagnostic medical devices. The devices are also classified based on risk, which determines the scale of data and the depth of evaluation required. The classifications are as follows:

  • Class I – Non-sterile or no measuring function (low risk)
  • Class I – Sterile and a measuring function (low/medium risk)
  • Class IIa (medium risk)
  • Class IIb (medium/high risk)
  • Class III (high risk)

Every device class has separate testing requirements, and devices with preinstalled software will also be audited and validated.

Clinical Testing Procedures

 Because most devices submitted to the FDA fall under the 510(k) process, clinical testing typically takes about 6 to 15 months, depending on the type of device and what it’s designed to do. The first step is to assign a device classification. From there, the multi-dimensional 510(k) submission includes the following evaluations:

  • Preliminary safety testing
  • Risk estimation
  • Hazard identification
  • Hazard management planning
  • Risk mitigation strategy planning
  • Risk control analysis
  • Risk control effectiveness verification
  • Overall residual risk analysis
  • Risk/benefit analysis
  • Final risk management review

Under the MDR, Class I devices are evaluated based on Annex IV and V and are exempted from conformity assessment for CE marking. Some Class I devices with medium risk and Class IIa devices may need to undergo conformity assessments based on Annex XI of the MDR (Part A). Class IIb and Class III devices need to have strong technical documentation and extensive risk evaluation during conformity assessments with notified bodies, and if they are implantable devices the MDR designates them for further testing under special provisions. Medical device makers also need to prove that the device is in conformity with basic safety and performance standards, and the technical documentation protocol includes the need to report future improvements in active implantation devices.

In part two of this post, we’ll look in detail at an area of compliance that’s especially relevant to language service providers – unique device identification (UDI).

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