Device certification

In the case of IVDs that require the involvement of a Notified Body, data on performance characteristics, the results of performance evaluation and device certificates issued by the Notified Body must be included in the submission. The Competent Authorities are responsible for entering the following information in a European medical device databank, EUDAMED ... 

Data relating to device certifications issued by Notified Bodies... 

National Board of Boiler and Pressure Vessel Inspectors, 2004. Pressure Relieving Device Certifications (Red Book NB-18). National Board of Boiler and Pressure Vessel Inspectors, Columbus, Ohio. 

Since 1998, all medical devices marketed in Europe (EEA) must bear the CE mark, which signifies conformity to the essential requirements of the MDD. The MDD harmonized the European requirements along with device certification and the inspection procedures for manufacturers to ensure the highest degree of safety and product quality of the medical devices throughout the EC. Most important was the requirement for a full quality assurance system (Annex II of the MDD, 93/42/EEC), which included design controls for new medical device products. This was in line with the ISO 9000 series of standards established for quality systems by the International Organization for Standardization. 

Combination capacity factors that have been determined by test and are acceptable to use are compiled by The National Board of Boiler and Pressure Vessel Inspectors in the Pressure Relief Device Certifications publication, NB-18 or the so-called Red Book. This publication lists the combination capacity factors to be used with a specific rupture device and relief valve by manufacturer rupture device/valve models. 

The Japanese regulatory process was revised in 2004, creating the Pharmaceutical and Medical Devices Agency (PMDA), and provisions relating to medical devices came into effect on April 1, 2005 [16], In Japan two submissions may be required a KIT Drug J-NDA submission and a separate Medical Device Certification the latter of these has to be filed with PMDA. It should be noted that the review timelines for KIT Drug and Medical Device Certification submissions... 

The designated notified body regulates CE marking and the final result of all the certification process (Fig. 9.2) is the achievement of a certificate of conformity that enables the mannfacturer to apply a CE marking to the product. A CE mark is a guarantee of medical device certification and registration and enables access to the entire EU market (European Commission, 2012). 

Fig. 9.2 Regulatory process for medical devices certification in Europe.

Certificate Holder s Data Report for Storage Tanks Certificate Holder s Data Report for Core Support Structures Certificate Holder s Data Report for Rupture Disk Devices Certificate Holder s Data Report for Components Supports Owner s Report for Inservice Inspections Owner s Report for Repairs or Replacements Repair/Replacement Certification Record Certificate Holder s Data Report for Tubular Products and Fittings Welded with Filler Metal... 

Accepted NDT devices are entered in State register of mesurement equipment allowed for use on the territory of Belarus and the certificates of the device type are isssued. 

The ADA maintains a Hst of certified dental materials and devices based upon the certification by the maker that the item complies with ADA specification and that the testing for specification compliance of the item is procured in Association laboratories. The ADA also maintains a Hst of classified dental materials and devices which prove to be acceptable or provisionally acceptable to the Association based upon data submitted by the apphcant and data available in the Hterature. 

Certified testing and approval for control-valve devices used in hazardous locations is normally procured by the manufacturer of the device. The manufacturer often goes to a third party laboratory for testing and certification. Applicable approval standards are available from CSA, CENELEC, EM, SAA, and UL. 

Testing, certification, and installation rules for reheving devices are extensive. Eveiy chemical engineer responsible for the design or operation of process units should become veiy familiar with these rules. The pressure-relief-device paragraphs are the only parts of Sec. TII, Division I, that are concerned with the installation and ongoing operation of the facility all other rules apply only to the design and manufacture of the vessel. 

Comparative references are devices which are used to verify that an item has the same properties as the reference. They may take the form of materials such as chemicals which are used in spectrographic analyzers or those used in tests for the presence of certain compounds in a mixture or they could be materials with certain finishes, textures, etc. Certificates should be produced and retained for such reference materials so that their validity is known to those who will use them. Materials that degrade over time should be dated and given a use by date. Care should be taken to avoid cross contamination and any degradation due to sunlight. A specification for each reference material should be prepared so that its properties can be verified. 

The capacity of the combination of the rupture disk device and the spring loaded safety or safety relief v alve may be established in accordance with the appropriate paragraphs of UG-132, Certification of Capacity of Safety Relief Valves in Combination with Non-reclosing Pressure Relief Devices. 

Certificate of exclusion from environmental assessment or assessment report as applicable Labelling of devices... 

Placing of Devices on the Market in the EU 197 Table 10.2 Certification activities of Notified Bodies. 

EC verification provides an alternative to the model of establishing a certified production QA system. Independent testing of either all devices, or a statistically representative sample of each batch, is conducted by or on behalf of the Notified Body, which then issues a certificate of conformity for the tests conducted. This is not a popular option due to the costs involved. The procedure is not capable of providing adequate assurance as to the sterility of devices. Instead, an assurance of sterility must be based on the application of a production QA system to the sterilisation process. 

Only three countries, Tunisia, Uganda and Zimbabwe, do not issue a GMP certificate. The drug regulatory authorities in these three countries do conduct GMP inspections, but do not issue a specific document which indicates that a manufacturing plant has attained GMP standards. The MCAZ does, however, provide a GMP certificate at the manufacturer s request to facilitate international registration and export of products. In Malaysia, various types of certificates are issued GMP certificates Certificate of Pharmaceutical Product for export and Certificate of Free Sale for medical devices and cosmetic products. Cyprus has no clear criteria for issuing a GMP certificate instead. 

Signature/certification management - providing devices and mandatory scenarios for individuals to sign and certify what they submit. 

In 1936, the first certificate was issued in Great Britain for an intrinsically safe electrical device which was not designed for application in mining operations. 

Finally, it must be pointed out that all explosion protection devices or systems used in practice may be used only when their pressure rating, flameproof, and functional testing have been proved by competent bodies and their test results including the limits of application are documented in a type test certificate. 

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