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|
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|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
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:
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 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.
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
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:
The List of Notified Bodies operating in your area available on request
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.
The procedure comprises the following actions:
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
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
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
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.
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.
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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