CE-märgistuse vastavushindamise protsess

The conformity assessment can be considered as the procedure through which compliance to the requirements of the MDR is demonstrated. The conformity assessment is the mandatory step that needs be performed in order to have a medical device in the European Market.  We went through already the QMS requirements related to design control, and related topics like design kontrollimine ja kinnitamine. Here, we are going to discuss about the conformity assessment, meaning the different ways a manufacturer has to demonstrate compliance to the general safety and performance requirements.

There are different types of conformity assessment procedures: 

1. Conformity assessment based on a kvaliteedijuhtimissüsteem and on assessment of technical documentation (annex IX)
2. Conformity assessment based on type-examination (annex X)
3. Conformity assessment based on product conformity verification (annex XI)

The choice of the specific conformity assessment depends on the class of risk of the medical device and on the specific choice of the medical device organization. Let’s have a look to the different types of conformity assessment and then we’ll have a look to the different possible certification routes for each class of risk. 

Quality Management System Audit

This is the standard audit of the quality management system. If the company is already ISO 13485 certified there should not be any problem, as all the QMS processes should already be under control and well managed. We have already been discussing about the QMS requirements for EU MDR , based on the Article 10 of the regulation.

Conformity assessment based on ELi tüübihindamine 

The so-called EU Type-Examination is outlined in the Anne X of the EL MDR 2017/745. it is a type of conformity assessment that involves the notified body and it is based on the assessment of the technical documentation, relevant life cycle process. It often involves the examination of a representative example of medical device sample to ensure compliance of the product to the EU MDR. Upon this assessment and the relayed successful results, the notified body will issue the EU Type-Examination that is compliant with the conformity assessment mentioned in Annex X of EU MDR.

Product Conformity Verification

This conformity route is detailed in the Annex XI of the EU MDR and it can be performed for the medical device with EU type Examination certificate. As specified in the Annex XI,  product verification shall be understood to be the procedure whereby after examination of every manufactured device, the manufacturer, by issuing an EU declaration of conformity,, shall be deemed to ensure and to declare that the devices which have been subject to the procedure set out in Sections 14 and 15 conform to the type described in the EU type-examination certificate and meet the requirements of this Regulation which apply to them.

Conformity Assessment for each Medical Device Class of risk

As mentioned before, the conformity routes depend from the class of risk of the device? Let’s see now all the possibilities for each class of device. 

For Class III devices, the conformity route could be performed based on Annex IX (quality management system audit) or alternatively it is possible to use the procedure set out in annex X for the type-examination may be performed in combination with the product conformity verification according to annex XI.

This is a procedure that is valid for class III devices except custom-made and investigational devices. 

For devices classified as class IIa and IIb, expect for custom-made devices and investigational devices, it s still valid the quality management system route according to Annex IX,  followed by chapter I and III as well as the assessment of the tehniline dokumentatsioon and chapter II. However, for class IIb implantable devices the assessment of the technical documentation must be performed for each device and should not be based on sampling. 

Alternatively, it is possible to apply the procedure as specified in annex X (type-examination) in combination with an assessment as specified in annex XI (product conformity verification). 

Finally, for Class I device, there is no involvment of the notified body, and the device can be placed on the market based on the Declaration of Conformity that is drafted by the manufacturer. Obviously, the technical dossier of class I device may be inspected in the framework of ISO 13485 audit, against the criteria of the section 4.2.3 – Medical Device File.

Järeldused

In conclusion, the different routes to demonstrate compliance to the EU MDR 2017/745 have been discussed in details for all the class of medical device. It is extremely important to fully understand the requirements associated to the conformity assessment, as it is one of the key factor for the CE marking process.

QualityMedDevi uudiskiri

QualityMedDev on veebiplatvorm, mis pakub laialdast tuge meditsiiniseadmete tootjatele ja nõustamisettevõtetele eeskirjade järgimise valdkonnas. Avaldame blogipostitusi kvaliteedijuhtimissüsteemi ja regulatiivsete teemade kohta ning pakume allalaadimiseks valmis ulatuslikku dokumentatsiooni, et toetada kvaliteedisüsteemi juurutamist ja hooldust või tootega seotud sertifikaate. QualityMedDev pakub meditsiiniseadmete tootjatele kvaliteedi- ja regulatiivsete küsimustega seotud konsultatsiooniteenust, ärge kartke meie teenuste kohta lisateavet spetsiaalne leht veebisaidilt. Toetame ehitamist uhiuus kvaliteedisüsteem ja/või valmistamine SW-ga seotud tehniline dokumentatsioon.

Avaldame ka perioodilisi uudiskirju, mille eesmärk on jagada teavet uute artiklite või dokumentide kohta, mis on QualityMedDevi veebisaidi kaudu kättesaadavaks tehtud.

Kui soovite olla kursis viimaste uudiste ja analüüsidega meditsiiniseadmete sektori reguleeriva maailma kohta, tellige meie uudiskiri, täites alloleva vormi.

Source: https://www.qualitymeddev.com/2021/07/19/conformity-assessment/