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The FDA and the MDR – Key Differences You Need to Know

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9 min read

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Argos Multilingual

Published on

20 Mar 2020

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 (The European Commission postponed the MDR Deadline for one year, to 26 May 2021, to give medical device companies a chance to focus on the current COVID-19 pandemic), 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.

UDI in the United States and European Union

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).

What is UDI? 

At its most basic, UDI is a system used to mark and identify medical devices within a healthcare supply chain. At present, the International Medical Device Regulator Forum (IMDRF), the FDA, and the European Commission are hammering out details for a globally consistent approach to UDI that will increase patient safety and help optimize patient care by setting up global standards. Let’s examine the key differences in existing approaches to see how they might be brought together under one roof.

The FDA Approach

The US FDA released, in September 2013 a rule which establishes that a unique device identifier number should be assigned by the device manufacturer to each version or model of a device, and that the unique device identifier should be both in human readable format and in AutoID format. In addition:

  • Single-use devices of all classes (except implants) sold individually do not need UDI (UDI must be on the bulk packaging, however)
  • Software distributed in packaged and unpackaged form may be identified with the same device identifier
  • Labelers are responsible for UDI
  • The FDA mentions disinfection and sterilization, but not cleaning

The EU Approach

The EU Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) were adopted in 2017 and define the requirements for the EU’s UDI system. One new concept that has been introduced by the EU regulations is the basic UDI-DI, which allows for the grouping of regulated medical devices within EUDAMED, the EU regulatory database for regulated medical devices. Some other stipulations include: 

  • UDIs on labels and software need to be identical
  • Manufacturers are responsible for labeling
  • Cleaning is considered processing for reusable devices

A helping hand

In a global marketplace, labels are naturally expected to be multilingual. However, new UDI formatting requirements reduce the size of external labeling space and make it harder to include multiple languages or use languages that take up more space. At Argos Multilingual, our translation, localization, and desktop publishing (DTP) specialists are ready to help your organization meet global requirements and best serve your customers. Click here to find out more!

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