MDR Medical Device Classcification

EU-MDR

Classifying the Medical Device

Class I Medical Devices

Medical devices class I have the lowest perceived risk.

Sub-classificationsIIsImIr
DescriptionsLow riskLow risk (Sterile)Low risk (Measuring Body Attributes)Low risk (Reused Device)
ExamplesCorrective glasses,  frames, manual wheelchairsInvacare 9000 XT 18" x 16"- Open-Box - Invacare Manual WheelchairsPersonal protection kits, Sterile Urine Bags, etc.Amazon.com: Universal Drainable Urine Bag 2 Litre with Lever Tap (X10):  Health & Personal CareStethoscopes, Weighing BalanceAmazon.com: Pro Physician Single Head Cardiology Stethoscope: Industrial &  ScientificSurgical forceps ( All type of SS/Tit surgical equipment’s sterilized and reused by hospitals)Sklar Surgical Instruments | Sklar Surgical Instruments
Type of certificationSelf-certification or self- declarationNotified BodyNotified BodyNotified Body

Class IIa Medical Devices

Medical devices of class IIa  usually constitute low to medium risk. Patients should use them for a short-term period, any less than 30 days.

ExamplesAll patient monitoring equipment, Syringes. Needles for syringes. Blood oxygen analyzers. Contact lenses. Crowns. Extracorporeal Circulation Devices. Infusion cannula. Muscle stimulators. Sterilizers for medical devices. Nebulizers. Ultrasound diagnostic equipment. External ECGs.INFUSION SET | Beybi Plastik FabrikasiIdeal Disposable Syringes with Needles Ideal Instruments - Syringes-Disposable  | Needles SyringesGetting a dental implant from a dental school can save you money - The  Washington Post4 Pack) ReliOn 30 Gauge Ultra Thin Lancets, 100 Ct - Walmart.com -  Walmart.com

Class IIb Medical Devices

They are medium to high-risk devices, and patients may use them for longer than 30 days.

ExamplesLasers Devices for application. Internal ECGs. RF Generators. Non-energized implants. Brachytherapy devices. Condoms. Defibrillators, external. Hemodialyzers. Incubators for babies. Infusion pumps. Lenses, intra-ocular. Lithotriptors. Lung ventilators. Anesthesia machines.
Blood Bag Photograph by Antonia Reeve/science Photo LibraryIntraocular lens - Wikipedia

All medical devices have the highest risk possible in this class, and permanent monitoring is required during their lifetime.

ExamplesEnergized implants All Intracardiac applications. Bone cements, with antibiotic. Catheters, angioplasty balloon. Catheters, with radioisotopes. Collagen implants. Contraceptive intrauterine devices (IUDs). Electrodes, neurocortical. Prosthetic heart valves. Shunts, carotid artery. Sutures, absorbable . Vascular stents. Bioactive implantable devices.
AE-FF273R, SUPPORT ONLY FOR FLAT BRAIN SPATULAS – AUSTOSBirth Control - Downey, CA & East Los Angeles, CA: FPA Women's Health

Broad Categories of the C.E. Requirements 

The requirements of the C.E. can be divided into two major categories. These are:

1. Quality system requirements: The manufacturer must comply with the requirements for developing and manufacturing the product.

2. Safety and reliability requirements: The product should meet the needs for biocompatibility, software validation, electrical safety, electromagnetic compatibility (E.M.C.), performance evidence, technical performance evidence, and pre-clinical and clinical evidence.

Pre-requisite for CE Marking 

To ensure getting the C.E. mark, one or more of the following requirements must be complied with:

1. Establish and maintain a Medical Quality Management System (Q.M.S.)

2. Test your product to demonstrate compliance with applicable standards

3. Prepare a Technical File / Design Dossier for each family of products you wish to obtain a C.E. mark.

4. Contract a European Authorized Representative. Referring to the MDR, we have a new CE certificate for the disposable syringe and infusion set with the needle. Click here to learn more about our factory.

ce certificate
CE certificate

5. Contract a Notified Body that will audit your Quality Management System and Technical Files / Design Dossiers.

6. Register your company and list your product with at least one European Competent Authority.

Critical steps in obtaining the C.E. marking

Step 1: Classification

The first step for any manufacturer is to examine its medical device carefully. What does the medical device intend to do, and how does it achieve this? Defining the characteristics of the medical device is a crucial and valuable step. Information on medical device classification and the ’18 Rules of Classification’ should be consulted.

A vital part of this step is identifying E.U. Directives and legislations, their implications for the manufacturer’s medical device, and ensuring all regulations therein are adhered to. It is important to note that the onus for this step is solely on the manufacturer.

Step 2: Identification

After the medical device has been classified, and the surrounding directives have been clearly underlined, the next step is to identify all relevant European Harmonized Standards and other essential health and safety requirements. This step is paramount in ensuring that the medical device is compliant with all standards mentioned above. A comprehensive literature on medical device compliance should be consulted. At this stage, it is also essential to find out if Notified Bodies are necessary to obtain the C.E. mark.

Step 3: Technical Documentation

To obtain a C.E. mark, the manufacturer must complete and compile the technical documentation to produce the Technical File. These can include–among other things–medical device tests, assessments, product inspections, and relevant audits. After this, the manufacturer could issue a Declaration of Conformity.

Step 4: Appointing a European Authorized Representative (E.A.R.)

ALL manufacturers located outside of the E.U. seeking a C.E. mark for their medical device must appoint a European Authorised Representative (or E.A.R.).

Step 5: Certification

In the case of class I products, a manufacturer will then be able to self-certify the medical device. For upper-class products, the manufacturer needs to work with a Notified Body to conduct an audit of the technical documentation.

Step 6: Affixing the CE Marking

Once the medical device is certified, the manufacturer is finally ready to affix the C.E. mark. A medical device’s C.E. marking must be affixed on both the device and the relevant packaging clearly and visibly, along with the details of the EAR.

Step 7: National Provisions

The final step is complying with the national requirements of every country in the EU.

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