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CE Certification Of Medical Devices


Why CE Marking Important?

Present world depends on the use of Medical Devices for the purposes of CARE & CURE. In contrast to drugs, their primary mode of action is not pharmacological, immunological or metabolic. Medical Devices range from hospital fixed equipment’s, Implants, surgical, monitoring equipment’s wheelchairs, sticking plasters, syringes, etc.

The product category of Medical Devices falls apart in three classes:
  • Medical devices (making up about 80% of the total including medical software),
  • In vitro diagnostics (IVDs) and
  • Active implantable medical devices (AIMDs).
EU Market introduction of Medical Devices is accomplished by CE Certification and registration, which are accomplished in compliance with national and international regulations. For certification, each country has appointed one or more authorities to perform the certification procedure. In Europe, these authorities are named notified bodies (NBs) and operate independently of each other. The objective of NBs is to assess the performance of Medical Devices in terms of performance and safety, while evidence of effectiveness is not required at the stage of certification.


European Union Directive on Medical Devices CE Mark

In Europe, registration of Medical Devices is subject to harmonized European directives established in the 1990s. The core legal framework consists of three directives named Directive 90/385/EEC regarding active implantable medical devices (AIMDD 90/385/EC), Directive 93/42/EEC regarding Medical Devices (MDD 93/42/EC) and the Directive 98/79/EC regarding in vitro diagnostic medical devices (IVDD 98/79/EC).

EU Directive Device Category Class / list NB Involvement European Registration
MDD93/42/EC Medical
Device
classI Eudamed
classIs
toassess “sterile”
or
“measure” aspect
classIm
classIIa
classIIb
classIII
IVDD98/79/EC High-riskIVD listA
listB
self-tests
Low-riskIVD other
AIMDD90/385/EC AIMD n/a

The above directives aim at ensuring a high level of protection of human health and safety and proper functioning. The directives define safety and performance requirements for Medical Devices sold in the EU and apply to both products and manufacturers.

The classes of medical devices that require involvement of a NB are specified in the below figure. Whether the involvement of a NB is necessary or not, the Manufacturer must draw up the Declaration of Conformity (DoC) to declare his sole responsibility for the conformity to the relevant Directive. The DOC is a Proof of compliance with EC respective Directive regulations.


 







Medical Device CE Marking

MDD 93/42/EC defines products into different classes, based on risk and intended use, which determine the relevant conformity assessment procedure. Medium or high risk products classified based on the degree of risk (class Is, Im, IIa, IIb and III). The CE Certification as per MDD requires a conformity assessment procedure involving a notified body. The stringency of the conformity assessment procedures depends on the class of the Medical Device for CE Marking.

The manufacturer must Implement ISO 13485 standard in combination with the respective guidance standard as the basis of the QMS or use an equivalent quality system suitable to fulfil the requirements of the MDD CE Certification.


Conformity Assessment Procedure for Different Medical Device Class
Annex I Is
Sterile
Im
Sterile
IIa IIb III
II ( +Section4 )           V
II ( -Section4 )   V V V V  
III         V V
IV   V V V V V
V   V V V V V
VI   V V V V  
VII V V V V    
Table2 - An Overview of the Conformity Assessment procedures suitable for specific classes of MDs
Additionally in Annex VIII, MDs are described that are excluded from CE Certification


Some examples per class of Medical Device are provided here below for an awareness purpose
  • Class I: Examination Gloves, non-sterile dressings, stethoscopes, handheld mirrors in dentistry etc.
  • Class IIa: Syringes for infusion pumps, adhesives for topical use, stents, tracheal tubes etc.
  • Class IIb: Intraocular Lens, Non-absorbable Sutures etc.
  • Class III: Heart valves, drug delivery systems, breast implants etc.

MedicalSoftware

Its big business of standalone software developers that meets the definition of a medical deviceunder the MDD. Software which drives a Medical Device or influences the use of a device falls automatically into the same class of medical device. Standalone software qualified as in vitro diagnostic medical device should be regulated according to the IVDD. Medical software classified as medical device Class IIa or IIb are:
  • IIa - PET datasets or CT datasets for follow-up tumor treatment, software for monitoring heart rate or other physiological parameters during routine checkups
  • IIb - radiotherapy planning system used to calculate the dose of ionizing radiation to be administered to the patient, software used for monitoring, insulin dosage.

In Vitro Diagnostic Medical Device(IVDs) for CE Marking

Off course IVDs are a type of Medical Device. They different from other medical devices as (a) no direct benefit of IVD to the patient but indirect based on further actions by the patient or healthcare professionals and (b) IVDs never pose a risk to a patient or a population directly.

The first step is to verify whether your product falls within the definition of an IVD in accordance with the IVDD 98/79/EC. MEDDEVs provide guidelines for classification of a Medical Device or Medical Software as an IVD or as Medical Device. The involvement of a NB is necessary for high-risk IVDs. IVDD subdivided into List A and List B.For all IVDs listed in List A or List B, the NB verifies the design of the Medical Device and its compliance with the Essential Requirements. Also, in most cases, the NB verifies the QMS(ISO 13485) of the manufacturer. If the IVD is not on the lists in Annex II, no involvement of the NB is necessary unless the Medical Device is designed for self-testing. Within IVDD 98/79/EC, manufacturers and authorized representatives can demonstrate compliance with the essential requirements through harmonized standards which are mandated by the EC to support the Directive. Once the necessary steps have been successfully completed, the CE marking must be affixed to the IVD.


Active Implantable Medical Device CE Marking

Active and non-active Medical Devices are discriminated and contribute to correct classification. An active medical device is by definition any medical device that relies for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity. The AIMDD specifically focuses on active implantable medical devices that are surgically or medically implanted into the human body. For all active implantable medical devices, the involvement of a NB is obligatory.


CE Certification

The European market approval provided in the way of a CE Certification, means compliance to harmonized standards, proper QMS implementation wherein the safety is stablished by the manufacturer. The List of CE Certification requirements available on request


Notified Bodies for Medical Device CE Mark

The designated NBs of specific EU member state and countries having a regulatory agreement with the EU are registered in the EU New Approach Notified and Designated Organizations (Nando) information system. The harmonized standards for a CE certificate may vary product NB, but obtaining CEmarking may require relatively little data:
  • for devices that are substantially equivalent to an existing product, a comparative literature review may be sufficient;
  • For certain low-risk class medical devices (Class I, no Is or Im), companies can certify the device themselves without the involvement of a NB.
  • Higher-risk devices almost always require human validation data, but (other than medicine trials) trials need not be randomized and often address safety but not efficacy.
The List of Notified Bodies operating in your area available on request


CE Marking Service Providers

It is recommend to take the service of quality, technically sound CE Marking service providers for your guidance. This matters a lot to avoid undue delay and cost.


CE Certification procedure

The procedure comprises the following actions:
  • Appoint good Consultant
  • Product Testing
  • Application with Notified Body
  • ISO 13485 Implementation
  • Submit Technical File / Design dossier to Notified Body
  • Reply to Notified Body Review comments
  • Site audit and issue Certificate based on compliance.

ISO 13485 Certificate

The requirements for approval of QMS are largely covered by the requirements to obtain an ISO 13485 certificate. The revised list of Harmonized standard released by EU recently considered.
The cost of Certification, Documentation and Implementation support available on request


Technical File for CE Marking

The purpose of a CE technical File (Design dossier) is to show compliance with the essential requirements for one single product (family).Technical file is a controlled document that will need to be updated WHEN and WHERE it undergoes changes or as relevant. The technical file is commonly based on a STED layout.
The core components of a technical file based on STED layout are available on request


Cost of CE Certification

The cost and duration of the CE Certification procedure dependent on the class and on the status of QMS (ISO 13485 Certificate) and the Technical File. The minimum duration of a certification procedure with a NB is twenty four weeks, but is typically much longer. The cost and duration of the certification procedure itself are dependent on the class. After that, yearly extension costs apply.
The cost of CE MarkingConsultants and Testing for your medical device available on request


Surveillance audit and extension

A CE mark expires after five years. Upon CE certification in the first year, two years of unannounced surveillance audits follow. As part of vigilance, the safety and intended use of the medical device is monitored after its introduction on the market post-marketing surveillance (PMS) and post-marketing clinical follow-up (PMCFU). In the fourth year, renewal of the CE mark can be applied for. The manufacturer or the authorized representative is requested to keep copies of the technical documentation at least 5 years, for IVDs and AIMDs at least 10 and 15 years, respectively, after the last product has been placed on the market.


Registration European Union

The Medical Device Directive dictates a European databank for Medical Devices, which is effective under the name Eudamed since May 2011. The aim of Eudamed is to strengthen market surveillance and transparency in the field of Medical Devices by providing competent authorities of European member states with fast access to information on manufacturers and authorized representatives, on devices and certificates and on vigilance and clinical investigation data.


Contact us. We deliver results

The CE Marking process can be a big challenge for new manufactures, small and medium manufacturers and even large manufacturers. The CE Mark Certificate is a CROWN that the manufacturer’s Medical Device has met the requirements of world widely accepted standard for Medical Device. In order to receive the CE Mark Certificate CROWN in a timely manner and meet your market deadlines, you need a partner that understands how to help, how to speed up, how to cut extra cost, where to do testing, whom to contact..


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