As a medical device company, you have more regulations and burdens than businesses in most other industries. You have an intense number of rules that you are required to follow to ensure that your devices meet defined standards. You also have the additional requirement of having to be able to demonstrate your compliance to Regulatory Authorities.
The Medical Devices Directive (MDD) gives manufacturers the ability to choose which conformity assessment you would like to use. While it may seem like having choices makes it easier, this is often confusing for new and seasoned medical device manufacturers alike.
Choosing the right conformity assessment will ensure that you get approval without wasting resources. Likewise, choosing the wrong assessment and failing approval will set back the launch of your product.
Because this choice is so critical to your overall success, you have to carefully consider your options and decide which is best for your company. To help, we'll explore the top considerations that will bring clarity into the right decision for your organization.
How To Decide Which Conformity Assessment Medical Device Companies Should Choose
Article 11 of the MDD lists all the choices that you have when it comes to choosing your device’s conformity assessments. The MDD gives you this flexibility because each manufacturer is different. What works well for one might not work as well for another.
All conformity assessments will require you to have technical documentation about your device that includes information about how it conforms to meet the Essential Requirements. The notified body will perform a technical documentation review of your submitted assessment. A document control system can be a great way to get organized and be prepared for this requirement in advance.
Even if you’re using a conforming quality management system, the notified body won’t issue an EC Certificate without this technical documentation. If you failed to get your EC Certificate, then you won’t be allowed to place the CE marking on your device.
Now, let’s take a look at six possible options for your conformity assessment.
The Six Conformity Assessment Options
Annex II. Full Quality Assurance System
The full quality assurance system conformity assessment is one of the more common assessments used. It includes a full review of your entire quality management system — design, manufacturing, and final inspection.
According to Annex 11.7, your device’s technical documents will be reviewed even if your device isn’t a class III device. When LNE/G-MED performs the assessment, their auditor will review the technical documentation during your on-site audit so that they can assess the device’s conformity to the Essential Requirements.
If your product is a class III device and you use Annex II, you also need to include a design dossier for the auditor to review for conformity to the Essential Requirements.
Annex III. EC Type Examination
In the EC Type Examination assessment, the notified body will examine a certain representative sample of the device for conformity to the Essential Requirements.
These assessments look similar to design dossier assessments. The notified body performs an off-site, in-depth review of the technical requirements. The EC Type Examination is the one that doesn’t include a quality management system component — however, it’s usually combined with another annex that does.
Annex IV. EC Verification
During EC Verification, the notified body will examine and test your product to verify its conformity. They will either test and assess each individual product, or they will use a statistical sampling method that makes sure they test and assess an adequate sample size to determine conformity.
If you pass, the notified body will certify each product or each batch. The certificate that they issue will only apply to that product or batch that they examine. While this assessment does not have quality management system requirements, it does have requirements for the manufacturer’s post-market surveillance system. It also requires you to provide technical documents on the devices that demonstrate conformity to the Essential Requirements.
Annex V. EC Declaration of Conformity – Production Quality Assurance
While Annex V shares some similarities with Annex II when it comes to quality management system requirements, it doesn’t include design requirements.
It requires you to have a quality management system for your manufacturing and a final inspection for your devices, but it does not require you to include a design system — so there may not be a design history file (DHF) in your technical documentation. Technical documentation is still a requirement, and in some cases, Annex V will be combined with Annex III.
Annex VI. EC Declaration of Conformity – Product Quality Assurance
As you move through the annexes, you’ll find that they have fewer required procedures in your quality management system.
Annex VI requires a quality system for your final inspection and testing, but you won’t need a quality management system that includes design or manufacturing.
For that reason, this assessment is typically combined with Annex III for class IIb devices — which can result in a lengthy review process for the device. This assessment may also not be feasible if the devices require a special manufacturing process.
Annex VII. EC Declaration of Conformity
Annex VII requires you to have a systematic procedure in place to collect post-market information about the devices in use in the field. During the assessment, you will be required to provide technical documentation to demonstrate conformity with the Essential Requirements.
What Type of Medical Device Do You Produce?
Certain assessments are only applicable to specific classes of medical devices. So, before choosing your assessment type, make sure that you understand the type of device that you’re producing and which class it resides in.
Class 1 Medical Devices
- Follow the device classifications of Annex IX of the MDD.
- Must meet the relevant essential requirements of Annex 1.
Class IIa Medical Devices
- Follow Annex IV for examination and testing of each product or homogeneous batch of products.
- Audit the production quality assurance system following Annex V.
- Audit the final inspection and testing under Annex VI.
- Audit the full quality assurance system under Annex II.
Class IIb Medical Devices
- You must perform either a full Annex II audit of your quality assurance system or
- Perform an Annex III type-examination along with option 1, 2, or 3 from the IIa class devices above.
Class III Medical Devices
- You must perform either a full Annex II audit of your quality assurance system, including a design dossier, or
- Perform an Annex III-type examination along with option 1, 2, or 3 from the IIa class devices above.
Where Does Your Company Fall in the Supply Chain?
Conformity assessments have different quality systems because the MDD understands that you may have a variety of responsibilities in the supply chain.
You may be designing and manufacturing your own device, or you could be simply the company putting your name on the device just before it ships — meaning that you would take responsibility as defined in Article 1.
It’s important for you to assess your company and quality system structures before choosing a conformity assessment that’s right for you. You don’t want to simply choose Annex II (full quality assurance system) because “everyone” else does.
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