With the inception of the European Medical Device Regulation, the medical sphere received something unique. However, the deadline for ensuring EU MDR’s compliance is imminent. As a matter of fact, these regulations require healthcare equipment manufacturers to embrace technological revolutions.
What Are the Duties And Scopes Of MDR Compliance?
EU regulators may have quality management and risk management systems. Besides, these regulators can conduct the clinical evaluation, compile all technical documentation, and apply conformity assessment techniques.
What to Know About MRD Checklist?
Now that you’ve understood its scopes and duties, here’s presenting everything about the EU MDR checklist. These are the tasks that you require including in the action plan. They are:
• Design concern
• Product concern
What to Learn About the Design Concerns?
There are four basic thumbs’ rules:
>> Firstly, it’s imperative to define the product classification on the basis of your intended motive or purpose. Remember that a few devices have already got an upper or lower position in the classification system. For this reason, it is important to consider paying attention to the devices attributed to a higher risk score (let’s say from the MDD 2nd Class to 3rd Class)
>> After this, you have to determine the general design as well as safety requirements.
>> You also need to have your risk management system and ready-to-activate specific control measures.
>> As an effective practice, you can encourage using the harmonized standards earlier than intended.
What to Learn About Product Concerns?
Follow the below-offered bullets to learn more about product concerns:
• Firstly, you need to list the product characteristics before checking against MDR to assess gaps
• You need to consider device performance and product evidence
• Next, you have to list the physical, biological, and chemical properties
• After this, you need to identify SVHCs or Substances of Very High Concern
• Now, you need to define the minimum level of the article you wish to investigate
• After doing so, you need to gather the information required for the technical documentation
• Always keep an eye on relevant legislation for the devices (RoHS, REACH, etc.)
• Next, you have to set up the clinical evaluation process
• Now, you need to ensure the availability of the technical documentation
• Design the post-marketing vigilance procedure before establishing the corrective action
• Designate for authorized representation in case the operations aren’t inside EU
• EUDAMED is where you have to register the product
• Collect information on the ability to cover liabilities financially
So, these are the tasks that you need to perform. However, each product will have its own sets of tasks, which you need to perform accordingly (as, if, and when required).