CE Marking for Medical Devices

 

As the world faces the COVID-19 pandemic together, we would like to reassure you by taking extensive actions to safeguard people and patients' safety, by managing the risk of infection. These actions are following the World Health Organization (WHO), respective to local government.

 

To ensure the devices used for testing and in the whole procedure to treat the patient need to be safe and quality devices that do not cause any harm to the health and wellbeing of the patients and the users. Products that are classified as medical devices, must be accounted for and reassure the safety, as they are associated with additional risks. CE certifying medical devices requires a different approach of requirements because it determines your product's risks.

 For your products to be placed on the European market, you need to understand and meet all the required Directives to ensure your product completes the CE Marking process efficiently and successfully. CE Marking Conformité Européenne expresses conformity with the European legislation, specifically with European directives and European regulations. For medical devices, the Medical Device Regulation MDR and the In-vitro Device Regulation IVDR fulfill the "essential requirements" as laid out in Annex I of MDD, respectively the "general safety and performance requirements to be followed" as laid out in Annex I of MDR. The second precondition the manufacturer performs is conformity assessment procedure depending on the risk.

 

Also, Check >>> CE Marking Certification in Sri Lanka.

 

What are the classifications of Medical Devices?

Classifying your MDs are an essential step in the certification process. Under the Medical Device Regulation (MDR) 2017/745, MDs fall under four classes  classification described in ISO 13485Certification Standard:

• Class I
• Class IIa
• Class IIb
• Class III

These classes are characterized under the risks involved in them, from lower to the highest.

The classification of your medical device depends on its characteristics described in Annex IX of the MDR 2017/745

-For how long period for which the MD is in use?

-Whether the MDs are surgically invasive?

-Whether the MDs is an implant or active device in nature?

-Whether the device contains a clearly defined medicinal substance?

 

Basis of classification

The initial point for certifying a medical device is defining the purpose of devices. The Intended Purpose will confirm whether your product is underlined under the definition of the Medical Devices and provide a basis for the rest of the certification process, including classification, evaluation, documentation, and labeling.

 

What Directives do MDs need to meet?

The EU Medical Device Regulation 2017/745 is the legislation for manufacturers to adapt to the MDR to be sold within the EU market.

The CE Marked Devices ensure the safety of the devices and the conformity of the requirements underlined by the legislation to make the product/devices acceptable by the public for use without concern about the risks involved.

CE-marked devices are thoroughly tested under the following EU directives by the third party for the conformity of the marking.

 

Procedure to develop CE Marking for the medical devices

Navigating the CE marking process is as easy as the following steps:

1. Classify your product - Class I, IIa, IIb, and III according to the classification rules.

• Class I- Devices with low risk such as external devices such as a bandage, etc;
• Class IIa/b - Devices with medium risk such as electro-medical devices and;
• Class III - Devices with high risk such as cardiovascular catheters

2.       Determine your certification process based on the risk involved in the devices you manufacture.

3.       Fulfill the essential requirements stated under the EU directives.

4.       Establish a monitoring system.

5.       Establish an accident reporting system

6.       Issue a Declaration of Conformity

7.       Save the documentation

8.       Register with the appropriate authorities in Europe