NBOG F 2017-7 Rev.1
Review of qualification for the authorisation of personnel (MDR)
Disclaimer: This document is an interactive version of the original MDCG document. We will keep it up-to-date.
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.
The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law.
This form has to be read in conjunction with the NBOG BPG 2017-2. Information has to be provided at the initial stage of selection and authorisation of personnel and every time the body review (1) the persons‘ qualification (i.e. when codes are added and when competence is periodically reviewed according to criteria for maintaining competence). Information given in the different sections should be supported by relevant documentation.
| Initial authorisation granted on Reason for the current update | dd/mm/yyyy periodic review of competence addition/deletion of codes modification of competence criteria others: __________________ | Date and version No _________ |
| 1 Personal data | |||||
| Title, name | |||||
| Working languages (2) | Understanding | Speaking | Writing | ||
| Employment status | |||||
| Internal employee of the applicant (same legal entity) full-time part-time, please indicate: _____% of working time | |||||
| External employee on contract basis | |||||
| Location of employment: __________________________ | |||||
| 2 Roles (3) | |||||||||||||
| Site auditor (SA) | Lead auditor (LA) Project leader (PL) | ||||||||||||
| Product reviewer (PR). If the product reviewer is responsible only for a specific non-code related area (e.g. testing, biological safety), please indicate the relevant area: ___________ | |||||||||||||
| Internal clinician (IC) | Clinical specialist (CS) | ||||||||||||
| Final reviewer (FR) | Decision maker (DM) | ||||||||||||
| Reference to the conformity assessment body’s competence criteria used for the purpose of this authorisation (i.e. document reference and version) including criteria for maintaining competence, and process of selection and authorisation of personnel: __________________ | |||||||||||||
| 3 Relevant education | |||||||||||||
| No | Date of completion and duration | Technical college / university | Relevant subject(s) | Type/level of qualification and official name of the qualification granted | |||||||||
| 3.1 | |||||||||||||
| 3.2 | |||||||||||||
| 3.3 | |||||||||||||
| 3.4 | |||||||||||||
| Comments: | |||||||||||||
| 4 Relevant working experience | |||||||||||||
| No | from – to | Employer | Department / position | Responsibilities with respect to design, manufacture, testing or use of device or technologies or experience in a conformity assessment body (please indicate the codes involved in each task) (4) | |||||||||
| 4.1 | |||||||||||||
| 4.2 | |||||||||||||
| 4.3 | |||||||||||||
| 4.4 | |||||||||||||
| 4.5 | |||||||||||||
| 4.6 | |||||||||||||
| 4.7 | |||||||||||||
| 4.8 | |||||||||||||
| 4.9 | |||||||||||||
| Comments: | |||||||||||||
| 5 Training and professional development | |||||||||||||
| No | Date of completion and number of days / hours | Name of the training provider / company / organisation / university providing the training, if applicable (5) | Title of the training and appropriate description of topics covered | Certificate granted, if any | |||||||||
| 5.1 | |||||||||||||
| 5.2 | |||||||||||||
| 5.3 | |||||||||||||
| 5.4 | |||||||||||||
| 5.5 | |||||||||||||
| 5.6 | |||||||||||||
| 5.7 | |||||||||||||
| 5.8 | |||||||||||||
| 5.9 | |||||||||||||
| Comments: | |||||||||||||
| 6 Other relevant experience | |||||||||||||
| 7 Authorisation to roles / functions and codes and rationale for this authorisation including reference to information given in sections 3-6 | ||||
| Codes | Roles (6) acc.to sec. 2 | Limitations per role (7) | Reference to sections 3 to 6 | Rationale per role for the initial authorisation and/or the maintenance / limitation of the authorisation justification in case that the combination of reference in the previous column is not self-explanatory or in case of derogations from the CAB competence criteria. |
| MDA 0101 Active implantable devices for stimulation / inhibition / monitoring | SA | |||
| PR | ||||
| IC | ||||
| CS | ||||
| FR | ||||
| DM | ||||
| MDA 0102 Active implantable devices delivering drugs or other substances | ||||
| MDA 0103 Active implantable devices substituting or replacing organ functions | ||||
| MDA 0104 Active implantable devices utilising radiation and other active implantable devices | ||||
| MDA 0201 Active non-implantable imaging devices utilising ionizing radiation | ||||
| MDA 0202 Active non-implantable imaging devices utilising non-ionizing radiation | ||||
| MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters | ||||
| MDA 0204 Other active non-implantable devices for monitoring and/or diagnosis | ||||
| MDA 0301 Active non-implantable devices utilising ionizing radiation | ||||
| MDA 0302 Active non-implantable devices utilising non-ionizing radiation | ||||
| MDA 0303 Active non-implantable devices utilising hyperthermia / hypothermia | ||||
| MDA 0304 Active non-implantable devices for shock-wave therapy (lithotripsy) | ||||
| MDA 0305 Active non-implantable devices for stimulation or inhibition | ||||
| MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis | ||||
| MDA 0307 Active non-implantable respiratory devices | ||||
| MDA 0308 Active non-implantable devices for wound and skin care | ||||
| MDA 0309 Active non-implantable ophthalmologic devices | ||||
| MDA 0310 Active non-implantable devices for ear, nose and throat | ||||
| MDA 0311 Active non-implantable dental devices | ||||
| MDA 0312 Other active non-implantable surgical devices | ||||
| MDA 0313 Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport | ||||
| MDA 0314 Active non-implantable devices for processing and preservation of human cells, tissues or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART) | ||||
| MDA 0315 Software | ||||
| MDA 0316 Medical gas supply systems and parts thereof | ||||
| MDA 0317 Active non-implantable devices for cleaning, disinfection and sterilisation | ||||
| MDA 0318 Other active non-implantable devices | ||||
| MDN 1101 Non-active cardiovascular, vascular and neurovascular implants | ||||
| MDN 1102 Non-active osteo- and orthopaedic implants | ||||
| MDN 1103 Non-active dental implants and dental materials | ||||
| MDN 1104 Non-active soft tissue and other implants | ||||
| MDN 1201 Non-active non-implantable devices for anaesthesia, emergency and intensive care | ||||
| MDN 1202 Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis | ||||
| MDN 1203 Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools | ||||
| MDN 1204 Non-active non-implantable devices for wound and skin care | ||||
| MDN 1205 Non-active non-implantable orthopaedic and rehabilitation devices | ||||
| MDN 1206 Non-active non-implantable ophthalmologic devices | ||||
| MDN 1207 Non-active non-implantable diagnostic devices | ||||
| MDN 1208 Non-active non-implantable instruments | ||||
| MDN 1209 Non-active non-implantable dental materials | ||||
| MDN 1210 Non-active non-implantable devices used for contraception or prevention of the transmission of sexually transmitted diseases | ||||
| MDN 1211 Non-active non-implantable devices for disinfecting, cleaning and rinsing | ||||
| MDN 1212 Non-active non-implantable devices for processing and preservation of human cells, tissue or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART) | ||||
| MDN 1213 Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route | ||||
| MDN 1214 General non-active non-implantable devices used in health care and other non-active non-implantable devices | ||||
| MDS 1001 Devices incorporating medicinal substances | ||||
| MDS 1002 Devices manufactured utilising tissues or cells of humanl origin, or their derivatives | ||||
| MDS 1003 Devices manufactured utilising tissues or cells of animal origin, or their derivatives | ||||
| MDS 1004 Devices which are also machinery as defined in point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council | ||||
| MDS 1005 Devices in sterile condition | ||||
| MDS 1006 Reusable surgical instruments | ||||
| MDS 1007 Devices incorporating or consisting of nanomaterial | ||||
| MDS 1008 Devices utilising biologically active coatings and / or materials or being wholly or mainly absorbed or locally dispersed in the human body or are intended to undergo a chemical change in the body | ||||
| MDS 1009 Devices incorporating software / utilising software / controlled by software, including devices intended for controlling, monitoring or directly influencing the performance of active or active implantable devices | ||||
| MDS 1010 Devices with a measuring function | ||||
| MDS 1011 Devices in systems or procedure packs | ||||
| MDS 1012 Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 | ||||
| MDS 1013 Class III custom-made implantable devices | ||||
| MDS 1014 Devices incorporating as an integral part an in vitrodiagnostic device | ||||
| MDT 2001 Devices manufactured using metal processing | ||||
| MDT 2002 Devices manufactured using plastic processing | ||||
| MDT 2003 Devices manufactured using non-metal mineral processing (e.g. glass, ceramics) | ||||
| MDT 2004 Devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper) | ||||
| MDT 2005 Devices manufactured using biotechnology | ||||
| MDT 2006 Devices manufactured using chemical processing | ||||
| MDT 2007 Devices which require knowledge regarding the production of pharmaceuticals | ||||
| MDT 2008 Devices manufactured in clean rooms and associated controlled environments | ||||
| MDT 2009 Devices manufactured using processing of materials of human, animal, or microbial origin | ||||
| MDT 2010 Devices manufactured using electronic components including communication devices | ||||
| MDT 2011 Devices which require packaging, including labelling | ||||
| MDT 2012 Devices which require installation, refurbishment | ||||
| MDT 2013 Devices which have undergone reprocessing | ||||
For completeness and correctness
| _________________________ date |
| _________________________ Personnel signature |
For granting of authorisation
| _________________________ date |
| _________________________ Personnel responsible for autorisation signature |
This is the original MDCG Template that is part of the NBOG F 2017-7 document Rev. 1.
Footnotes
(1): It is expected that a review will also be performed every time the conformity assessment body competence criteria are upgraded.
(2): To be indicated in accordance with the Common European Framework of Reference for Languages, taking into account the supporting documentation provided by the person.
(3): Additional roles defined by the applicant CAB should be added to this table.
(4): In case the number of QMS audits or technical file reviews carried out are part of the competence criteria established by the notified body (e.g. minimum 40 hours CE certification audit) a reference should be provided to the specific manufacturer, role performed by the expert and relevant codes involved. When the experience has been acquired internally, the notified body should make the relevant log available upon request. When acquired externally statements / logs from the former employers should be made available.
(5): It is expected that this information will always be given except in the case of self-training.
(6): As many lines as roles included in the scope of authorisation of the person should be included as per the example given for code MDA 0101.
(7): When a product reviewer is authorised only for a specific non –code related area, or in case the person’s authorisation is limited to a specific area (e.g. clinical experts) such area should also be indicated in this column.
Revision History
February 2018
Rev.1
Redline Version
May 2017
Rev.0