Dear clients,
Below you will find answers to questions sent after the seminar "Using Accreditation in the Regulated Area", which took place on January 23, 2019 in Prague.
Based on the interest shown, CAI is considering implementing a workshop focused on the applicable requirements of the standards ČSN EN ISO/IEC 17020:2012, ČSN EN ISO/IEC 17021-1:2016 and ČSN EN ISO/IEC 17025:2018.
The topic of the legislative process was interesting to me. I believe that the amendments to Acts 22/1997 Coll. and 90/2016 Coll. are slowly responding to developments in this area. I miss, for example, the link to the prepared Act on Reserved Technical Equipment. Is it being addressed?
CAI is not the proponent of any of the identified laws and it is not its place to speculate about their connections.
BIf an audio recording is made, where will it be stored?
No.
Examples of COV certificates, authorization/notification part – NV 163/2002.
Instructions for completing Annex No. 3 for COV are published on the CAI website.
What specific changes are planned in the upcoming new revision of the EA 2/17 document?
The new revision of EA-2/17 will place greater emphasis on the so-called preferred standards. The applicable requirements for individual standards will be newly specified. A new model of the annex to the accreditation certificate will be included in the body of the document and will be binding. New requirements for the number of witness audits will be set out in the informative annex.
Will it be possible to enter the comment procedure for the new revision of document EA 2/17?
Except for comments in the EA, the document will be commented on within the EU IMP.
If AO and OS can combine and use common elements of standards (17020, 17065, 17021, 17025), how will CAI assess this when assessing COV, IO, COSM? This means that during the IO audit it will also assess COV or COSM?
In case of interest from the CAI entity, it carries out a so-called parallel assessment, see Annex No. 3 MPA 00-01-..
During accreditation for the purposes of authorization/notification, applicable requirements from other standards relevant to a specific module are also assessed for the IO, i.e. the conformity assessment procedure - for more information, see EA-2/17M:2016.
Does the inspection according to the requirements of, for example, the TKP MdČR fall within the scope of the inspection bodies' activities?
The suitability of using inspection to assess compliance with the requirements specified in the documents in question must be assessed on the basis of the specific requirements. In general, the suitability of inspection cannot be ruled out.
The form of a seminar without the possibility of on-site questions is completely unsatisfactory and unprofitable for the subjects. The issue cannot be resolved by correspondence.
In view of the interest of CAI and ÚNMZ to proceed in a unified and undivided manner, CAI decided, with the consent of ÚNMZ, that there would be no room for discussion at this seminar. At the same time, the non-disclosure of the discussion was a reaction to the information about the planned discussion of AAAO on Guideline P1. Another reason was the non-participation of ÚNMZ management at this seminar.
I liked Mgr. Vácha's lecture, but she pointed out the expansion of the definition of WA in MPA 00_01_18 compared to ISO 17011. AAAO considers this incorrect and demands consistent use of the definitions from the standard.
The definition in MPA 00-01 combines the definitions of ISO/IEC 17011:
MPA 00-01-..:
Witness audit: observation by the accreditation body of how a body carries out the conformity assessment activities for which accreditation is sought or granted.
ISO/IEC 17011:
3.6 scope of accreditation – specific conformity assessment activities for which accreditation (3.1) is requested or granted.
3.25 witnessing – observation by an accreditation body (3.2) of a conformity assessment body (3.4) carrying out conformity assessment activities falling within its scope of accreditation (3.6).
ERA Technical Document 000MRA1044, which extends the requirements for COVs under 17065 for authorization purposes.
See ERA Information.
Accreditation for authorization/notification purposes - but in the version of how it will actually be carried out in practice by CAI and how it will actually be accepted and processed by UNMZ.
Instructions for completing Annex No. 3 for COV are published on the CAI website.
Who is currently the notifying authority under Act 22/1997 for Directive (EU) 2016/797 - the current status does not allow for activity under this directive, even though new technical specifications under this directive have already been issued (will be issued) with immediate effect.
ÚNMZ: The Member State has not yet appointed a notifying authority as specified in Directive (EU) 2016/797. Negotiations are currently underway with the Ministry of Interior of the Czech Republic.
Announcing the first opportunity to perform a WA one month in advance is unrealistic in most cases.
Considering the time constraints of internal and external staff, 30 days notice of readiness for WA is necessary.
Who is or will be the responsible party for medical devices if accreditation is not/will not be required for AO/NB/OS? Will it be the Ministry of Health (ÚNMZ) or the Ministry of Health of the Czech Republic (SÚKL)?
ÚNMZ: The Ministry of Health of the Czech Republic has appointed ÚNMZ as the authority responsible for notified bodies under the MDR and IVDR. However, the adaptation has not yet been carried out and the law has not provided for it. We have already sent you a statement on the possibility of accreditation in this area in the past.
Question about Instruction P1
It is very important for a notified body to be able to react flexibly and economically, otherwise it loses its competitiveness. As a result, manufacturers also lose their market position if they cannot market their product because “their” notified body is not notified in time and therefore cannot certify their product.
Our experience from the past
OS was interested in notification according to hEN. At a time when this standard was still in the prEN phase, OS had already applied to CAI for the extension of COV accreditation to include this standard, preferably as part of regular surveillance (saving costs for extraordinary surveillance). CAI issued an accreditation certificate stating this prEN. Within, for example, 4 months, this prEN was published as an EN and was harmonized. At this time, OS applied to ÚNMZ for notification and provided an accreditation certificate with prEN. ÚNMZ notified OS for the relevant hEN. During subsequent regular surveillance, CAI issued an accreditation certificate for hEN.
Proposed present
The OS/COV will have the CAI accredit the prEN as part of regular supervision and, when the standard is harmonized, the ÚNMZ will request notification according to Guideline P1 Variant B. According to this variant, however, the OS must provide evidence of the requirements listed in Variant A, which are assessed by the CAI. This clearly forces the OS to use Variant A (the ÚNMZ also recommends it).
Therefore, if the OS decides to follow Option A, i.e. to be accredited by CAI for notification purposes, there is a catch. CAI only accredits standards for notification purposes that have already been harmonized.
So the procedure would be as follows
The OS knows that a new harmonized standard is being prepared and will be published, but it cannot apply for accreditation while the standard is in the prEN or EN phase without harmonization. When the standard is harmonized, the COV applies for an extension of accreditation for notification purposes (which will in most cases result in extraordinary supervision, and thus higher costs again). Even with good will, accreditation takes at least 2 months. Then the OS applies to the ÚNMZ for notification, which takes another 4 months. This results in at least 6 months plus costs for extraordinary accreditation before the OS is notified. And we also consider the fact that hEN is harmonized with a transition period.
But what if there is no transition period, e.g., hEN amendment? 6 months without notification means a loss of competitiveness for both OS and manufacturers, as mentioned at the beginning.
ÚNMZ: Regarding the above issue, I would like to state that the matter should be resolved with flexibility. I believe that all other notified bodies in the given area are facing the same situation. Therefore, I recommend that this be resolved in working groups of national accreditation bodies, with the EC expressing its opinion on this.