Conformity (conformance) certification of medical devices, including X-ray equipment

Diagnostic radiology equipment as well as equipment for nuclear medicine and radiation therapy belong to directive 93/42/EEC, the so-called Medical Device Directive, in short form MDD which is valid in the EU since 1998.06.15. It was adopted in Hungary by Decree No. 47/1999. (X.6.) of the Minister of Health about medical devices, which later was replaced by Decree No. 4/2009. (III.19.) of the Minister of Health. Annex I of the directive as well as that of the decree contains the essential requirements. Annexes of the decree are literal translations of those of the directive. There is only one deviation: subclause 13.7 of (the first part of) Annex I states: “Items stated in subclauses 13.1 to 13.6 must be available for the end user of the equipment in Hungarian language”. (These are requirements for contents of user’s manual and labels).

According to the regulation, these equipment belong to class IIb, while their non-active accessories as film cassettes, intensifying screens, grids etc. to class IIa. In these cases contribution of an NB is obligatory. Then beside (under) the CE marking there has always to be a four-digit number which identifies the certifying NB according to the Brussels register.

In case of products of class IIb manufacturer may choose from the following conformity certifying procedures:
a) Full quality assurance system according to Annex 2 in such a way that test according to 4th section of Annex 2 is not necessary; or
b) Type testing procedure according to Annex 3, connected with either
ba) EC verification (i.e. product QC by an NB) according to Annex 4, or
bb) Production quality assurance according to Annex 5, or
bc) Product quality assurance according to Annex 6.

It must be noted that for diagnostic radiology equipment (radiographic, fluoroscopic, mammography, dental, CT) Radiohygiene Department Laboratory of NRIRR is accredited for testing according to Annex 3 and standards harmonized to the directive, respectively. The Laboratory may perform such testing as an accredited subcontractor of an ordering a NB. In case of conformity assessment pathway according to the former item b), the four-digit number, to be indicated beside CE marking is always the registration number of the NB which performs the system certification (and not the type certification, if the two NBs are different).

Essential requirements concerning radiation protection of the product are contained in subclause 11. of (the first part of) Annex I of the decree. In case of diagnostic radiology equipment it has to be taken as satisfied if the product conforms to collateral standard IEC/EN 60601-1-3 and – if any – also to the particular standard(s) from the 6061-2 series to be applied to it (e.g. for a mammography equipment IEC 60601-2-45).

In cases when contribution of an NB is obligatory, asking for a copy of the Certificate of the manufacturer (or in case of type certification that of the type, in case of “EC verification” that of the individual product) given by a NB, is also a part of the procedure for checking legality of CE marking. In procedures combined with type testing, it means two certificates. However, almost 100 per cent of manufacturers choose the full quality assurance system according to item a); in this case there is one certificate only.

It is important to note that full quality assurance system of the manufacturer has to conform mainly to the corresponding Annex of the directive, and certificate has to certify this fact. It is possible that there is a separate certificate of conformity of full quality assurance system according to ISO 9001 (it may also by combined with ISO 13485, earlier series 46001) but as it means certifying satisfaction of less requirements, it can not substitute certification of full quality assurance system according to the directive.