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The new legislation will cover (in one common ministerial decree): 90/385/EEC Active Implantable Medical Devices Directive 93/42/EEC Medical Devices Directive (Amendments of MDD in the new IVD 98/79/EC) Each Annex translated word for word!.

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slide7
The new legislation will cover (in one common ministerial decree):

90/385/EEC Active Implantable Medical Devices Directive

93/42/EEC Medical Devices Directive

(Amendments of MDD in the new IVD 98/79/EC)

Each Annex translated word for word!

slide9
Main features of Phase 1. (old legislation):

Each type of MD shall be tested on safety and performance (regardless of its risk class)

Each type of MD shall be tested medically but not acc. to EN 540 (regardless of its risk class)

Not a certificate but a kind of permit

slide10
Main features of Phase 2. (new legislation):

Free movement of Class I MDs with CE marking (non-sterile, no measuring function)

Certificates of Annexes (of MDD) II, V, VI and III will not be accepted, proc.s shall be repeated

Safeguard clause & vigilance on national level

Manufacturer/dealer/repr.: resident in Hungary

Nat. reg. of man.s/dealers/repr.s and of certi-ficates: acc. to EUDAMED (DIMDI)

National Conformity Assessment Body (CAB)

slide11
Main features of Phase 3. (PECA in force):

Certificates of Annexes (of MDD) II, V, VI and III will be mutually accepted (on our side, for medical devices of Hungarian origin only)

Safeguard clause & vigilance on EU level

Manufacturer/dealer/repr.: resident in Hungary

Active access to EUDAMED database (also to add data via our Competent Authority)

CAB  Notified Body (in EU-sense) - following a “confidence building period”

slide12
Main features of Phase 4. (EU-membership):

Activity of Hungarian Notified Body (Bodies) not restricted to MDs of Hungarian origin

Manufacturer/dealer/repr.: EU-resident

PECA not necessary at any more

Remark: we do our best to avoid or at least to shorten the problematic Phase 2. (Application of the Directives without a mutual recognition.)

comp 1 the acceptance of ce marking for mds
Old regulation:

Not

(The procedure, of course, can be essen-tially accelerated and supported by present-ing documents ac-cording to Technical File and/or Design Dossier)

New regulation:

Phase 2.: Class I MDs (non-sterile, no meas. function): YES. Others: Not (only support as at Old reg.)

Phases 3. and 4.: Yes, CE marking will be (mutually) accepted

Comp. 1: The acceptance of CE marking for MDs.
comp 2 acceptance of tests performed for conf ass
Old regulation:

It is the freedom of our Institute but test results of NBs of good reputation are accepted in general. This is not valid for certificates especially for those according to Annex III of MDD.

New regulation:

Phase 2.: See at old regulation.

Phase 3. and 4.: Yes in general supposed the tests have been performed by a Notified Body within the EU.

Comp. 2: Acceptance of tests performed for conf.ass.
comp 3 cost for registration of medical devices
Old regulation:

Fixed prices (According to No. 50/1996. (XII.27.) NM Regulation)

New regulation:

We intent to keep our prices by 25-30 % below prices of our competitors in Phase 2 also. (Non-Hungarian companies later can use this advantage only after joining of Hungary to the EU.)

Comp. 3: Cost for registration of medical devices.
comp 4 schedule duration of registr procedures
Old regulation:

Duration of comp-ulsory medical testing and results (implants) is determining

Having medical test protocols (and other EU documentation), 2-3 months as a maximum

New regulation:

After presentation of all EU documents (Technical File, Design Dossier)

and fulfilment of language requirements: 2-3 months as a maximum

Comp. 4: Schedule, duration of registr. procedures.
comp 5 number quantity of free samples
Old regulation:

Necessary for the medical tests (trials) to be performed in a national health care institution designated by ORKI. - Note: this is not a detailed clin-ical investigation in the sense of EN 540

New regulation:

General rules of EN 540 apply.

Clinical investiga- tion can be performed not in Hungary only; results in strict (close) accordance with EN 540 can be accepted

Comp. 5: Number (quantity) of free samples.
comp 6 language requirements for prof use
Old regulation:

Instructions for Use of implants (profes-sional use only !): English is allowed, but Hungarian is preferable

Patient information booklets and sheets: only Hungarian is allowed !

New regulation:

Instructions for Use of implants (profes-sional use only !): English is allowed, but Hungarian is preferable

Patient information booklets and sheets: only Hungarian is allowed !

Comp. 6: Language requirements for prof. use.
comp 7 requirements for device package labelling
Old regulation:

Nowadays already requirements of MDD and AIMD are requested (see under “New regulation”)

New regulation:

According to Clause 13. of Annex I (MDD) or Clauses 12, 13, 14 of Annex 1. (AIMD)

Information available for the patient: in Hungarian; for med. professionals only: preferable in Hung., possible in English

Comp. 7: Requirements for device/package labelling.
comp 8 technical documentation requested
Old regulation:

Medical test protocol prepared in Hungary

Sterility validation test (in Hungary), etc.

Relevant parts of Technical File and of Design Dossier (English is tolerated)

New regulation:

Clinical investigation docum. acc. to EN 450

Technical File and Design Dossier (incl. risk analysis)

Documents in English tolerated; sometimes upon agreement in French or German also acceptable

Comp. 8: Technical documentation requested.