Pre-audit including gap analysis regarding CE marking

Transcription

1 LIFE 10 ENV/SE037 April 2017 Pre-audit including gap analysis regarding CE marking Author: Alice Ravizza Background The blood bag is a class IIb Medical device. It is a set of 4 bags intended to collect donated blood, preserve it during transportation, process it and store the blood components for further re-infusion. The PVC free blood bag is designed to comply to the expected Medical Device Regulation, which latest released draft (22 February 2017) limits the use of some substances including phthalates (reference Annex I, ) The set of bags was designed by one of the participants of the project, Haemotronic (Italy) according to their ISO quality management system and the Technical File. Design process was carried out in compliance to the Haemotronic procedure for Design control and followed the steps - Input form Cod Rev 0 of 05/11/10 - -outputs form cod verification and validations according to dedicated Validation Plans The output of such process was the creation of two different documents: - design history file DHF including the history of design and development of the device - technical file including proof of compliance to the regulatory requirements (Medical Device Directive 93/42 and appropriate sections of Medical Device Regulation draft) Chosen path to CE mark Haemotronic already holds various CE marked devices, all paced on the market according to Medical Device Directive Annex II except of Point 4 This path is also defined as the full quality assurance path. In this case, the manufacturer must: - implement a quality management system: already present in Haemotronic, ISO certified by DNV GL 1(3)

2 - implement a Product Technical File - obtain approval of Product Technical File by a Notified Body, requested to Italcert - ensure continuous application of the quality system approved for the design, manufacture and final inspection of the products: application of the quality system must ensure that the products conform to the regulatory requirements and to the Technical File at every stage, from design to final inspection - obtain approval of such continuous application by a Notified Body Technical File The Technical file was prepared by Alice Ravizza and approved by Luigi Ravizza 9 March The content of the Technical File is listed below. 1. Introduction Brief product description Intended Use and intended performance Indication Contraindications and Warnings Accessories for the product, Integral parts of package Packaging Planned changes Conformity Assessment Route that has been chosen Applicable norms 7 2. Essential Requirements Checklist 8 3. Risk Analysis 8 4. Product Specifications Product specifications Product design control summary Product manufacturing summary Chemical, physical and biological tests Technical Testing - Preclinical Studies Biocompatibility Tests User testing Clinical Performance Data Package Qualification and Shelf life Labels - Instructions for use - patient information - advertising material Sterilization Conclusion Declaration of Conformity (Draft) Annexes 22 2(3)

3 Result The device is not ready for CE marking as some Essential Requirements are not completely met. 1. Essential Requirement 4 and 5 regarding shelf life evaluation: the device may undergo shelf life and transportation testing only after the sterilization cycle is validated 2. Essential Requirement 6 regarding clinical data evaluation: the device was tested for the capacity of preservation of red cells and met regulator requirements for up to 28 days. This time length is shorter than the state of the art; different preservation solutions may improve storage time. Moreover, there are currently no data on plasma preservation. 3. Essential Requirement 8.3 and 8.4 regarding sterilization: the device is compatible with Steam and Gamma sterilization, in appropriate containers. The sterilization cycles are not yet validated. The validation of such cycles requires the manufacturing of at least 3 commercial lots, which is currently out of the project scope. Annex: 1. Offer from ItalCert 2. Data about ItalCert 3. Pre-audit report no 1062 from Italcert 24 March (3)

4

5

6

7

8

9

10 Notification of a Body in the framework of a technical harmonization directive From : Ministero dello Sviluppo Economico - Direzione Generale per il Mercato, la Concorrenza, il Consumatore, la Vigilanza e la Normativa Tecnica Via Sallustiana, ROMA Italy To : European Commission GROWTH Directorate-General 200 Rue de la Loi, B-1049 Brussels. Other Member States Reference : Legislation : 93/42/EEC Medical devices Body name, address, telephone, fax, , website : ITALCERT SRL Viale Sarca, MILANO Italy Phone : Fax : italcert@italcert.it Website : Body : NB 0426 Created : Unknown (Notifications pre-dating 2006 are not available in these lists) Last update : 22/12/2009 The body is assessed according to : EN EN ISO/IEC The competence of the body was assessed by : Ministero della salute e Ministero dello sviluppo economico The assessment of the body covers the product categories and conformity assessment procedures concerned by this notification : Yes 1 / 5

11 Tasks performed by the Body : Created : 24/07/2015 Last update : 03/08/2015 Product family, product /Intended use/product range *MD General non-active, non-implantable medical devices - *MD Non-active devices for anaesthesia, emergency and intensive care Procedure/Modules - *MD Non-active devices for injection, infusion, transfusion and dialysis - *MD Non-active orthopaedic and rehabilitation devices - *MD Non-active medical devices with measuring function - *MD Non-active ophthalmologic devices - *MD Non-active instruments - *MD Contraceptive medical devices - *MD Non-active medical devices for disinfecting, cleaning, rinsing *MD Non-active implants - *MD Non-active orthopaedic implants - *MD Non-active functional implants Annexes or articles of the directives I I I I I I I I I I Limitations, except surgically devices, intended for transient use, in direct contact with central nervous system, except hip, knee and shoulder joint replacements and except orthopaedic implants utilizing biological active coatings and/or materials or being wholly or mainly absorbed 2 / 5

12 Product family, product /Intended use/product range Procedure/Modules - *MD Non-active soft tissue implants *MD Devices for wound care - *MD Bandages and wound dressings - *MD Suture material and clamps - *MD Other medical devices for wound care *MD Non-active dental devices and accessories - *MD Non-active dental equipment and instruments - *MD Dental materials - *MD Dental implants *MD General active medical devices - *MD Devices for extra-corporal circulation, infusion and haemopheresis - *MD Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia - *MD Devices for stimulation or inhibition - *MD Active surgical devices Annexes or articles of the directives I I I I I I I I I I I Limitations, except dental implants utilizing biological active coatings and/or materials or being wholly or mainly absorbed 3 / 5

13 Product family, product /Intended use/product range Procedure/Modules - *MD Active ophthalmologic devices - *MD Active dental devices - *MD Active devices for disinfection and sterilisation - *MD Active rehabilitation devices and active prostheses - *MD Software *MD Devices for imaging - *MD Imaging devices utilising non-ionizing radiation *MD Monitoring devices - *MD Monitoring devices of non-vital physiological parameters - *MD Monitoring devices of vital physiological parameters *MD Devices for radiation therapy and thermo therapy - *MD Devices utilising non-ionizing radiation - *MD Devices for hyperthermia / hypothermia Annexes or articles of the directives I I I I I I I I I I Limitations 4 / 5

14 Horizontal technical competence *MDS Medical devices referencing the Directive 2006/42/EC on machinery *MDS Medical devices in sterile condition *MDS Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbed Limitations, except surgically devices, intended for transient use, in direct contact with central nervous system; hip, knee and shoulder joint replacements and orthopaedic and dental implants utilizing biological active coatings and/or materials or being wholly or mainly absorbed Orthopaedic and dental implants only 5 / 5

15 ITALCERT Istituto RRC DM STAGE 1 n 1062 STAGE 1 AUDIT REPORT CERTIFICATION ISO CERTIFICATION DIR. 93/42/EEC page 1 of 4 Section 1 GENERAL DATA Company Name HAEMOTRONIC S.p.A. Registred Office Via Carreri, Mirandola (MO) ITALY Checked Operative Unit Via Carreri, Mirandola (MO) ITALY Operative Unit checked during Stage 1 Audit Via Carreri, Mirandola (MO) - ITALY Standard ISO 9001:2008 ISO 9001:2015 UNI CEI EN ISO 13485:2012 UNI CEI EN ISO 13485:2016 Dir.93/42/EEC People (employees and not employees) at full time involved in certification activities: 8 People (employees and not employees) at part time involved in certification activities: Average Time (in percent respect to full-time people) of activities of part time people (Only for seasonal activities) maximum period and number of employees during maximum period Shift work YES NO Outside open construction sites: of which with > 200 days/man Date of Audit 24th March 2017 Audit Team Vendramin Christian (Team Leader) (Esperto) Villa Tomaso (Auditor) (Esperto) Section 2 Information about Certification Object of Certification --- Sector IAF --- Technical Areas IAF MD 09 (ISO 13485) In case of multisite certification Address sites Site 1: NBOG (directiv 93/42/CEE) --- Processes for every sites Site 2: DM10 rev. 02 feb-17 pagina 1 di 4

16 ITALCERT Istituto RRC DM STAGE 1 n 1062 STAGE 1 AUDIT REPORT CERTIFICATION ISO CERTIFICATION DIR. 93/42/EEC page 2 of 4 Object of Certification directive 93/42/EEC BLOOD BAGS (Class IIb - rule n 18 according to annex IX directive 93/42/EEC) directive 93/42/EEC (to indicate annex) (Excluding point 4) Technical areas NBOG (directive 93/42/EEC): MD 0102 Non-active devices for injection, infusion, transfusion and dialysis Section 3 People interviewed Name Role Name Role Luigi Ravizza Manager Lena Stigh Project Manager Name of consultant and its society (if available) Ing. Alice RAVIZZA Section 4 Information about certification Accettable exclusions (only for QMS) Comments about exclusions (only for QMS) List permissions required to carry out the activities directly related to the subject of certification. Indications for stage 2 audit Sites or external activities to auditing during stage 2 audit Only annex II excluding point 4 HAEMOTRONIC has certified its QMS with DNV for ISO 9001 and ISO standards ISO 9001: Cert. n AQ-IND-SINCERT of , Expire ISO 13485: Cert. n AQ-IND- SINCERT of , Expire "Field of application: Design, production, control, chemical / microbiological analysis and sale of bags, lines, accessories, components and semi-finished products for dialysis, administration, infusional applications, transfusion and urological applications". Business Profile of no comments The company has an operative site in Via Ugo Roncada, 83 - Carbonara di Po (MN), which is not part of the certification since all the processes applicable to the product are carried out at the Mirandola site. (See page 1 "Certified Operations Locations"). Critical Suppliers: Pickup and Filter System: FRESENIUS Pipeline System: First Profile (Poland) Outsourcing Processes: Sterilization Gamma - STERIGENICS Not yet identified the supplier for steam sterilization DM10 rev. 02 feb-17 pagina 2 di 4

17 ITALCERT Istituto RRC DM STAGE 1 n 1062 STAGE 1 AUDIT REPORT CERTIFICATION ISO CERTIFICATION DIR. 93/42/EEC page 3 of 4 Section 5 Review of the documentation Identification of Quality Manual (revision and or edition and its date of issue) MQ Rev. 35 dated Aspects to be evaluated YES NO NA The manual contains an overview of the organization with the summary of the activities carried out and adequate information to identify the organizational structure Has been identified the application field of QMS clearly and not overly generic Have been adequately justified the exclusions requested The Quality Manual contains itself the documented procedures (or referring to them) The Quality Manual contains identification of processes e their interaction The outsourced processes (if any) have been highlighted and identified the methods used to control them Section 6 LEVEL OF PREPARATION OF QMS Aspects to be evaluated for QMS YES NO NA The documentation cover and meet all requirements of the standard Internal audits planned to cover all the processes Internal audits were carried out Last audit performed Planned by March 2017 The management review is planned The Review is planned by April 2017 The management review was performed Last review performed It s was identified a member of the management covering the role of the management representative? General Manager Dr. Luigi RAVIZZA The organization has identified the processes It s possible to carry out the stage 2 audit Section 7 Observation or needs to update or modifying about quality system management documentation No. Ref. document Observation Technical File FT15 Rev. 0 of Technical File FT15 Rev. 0 of Technical File FT15 Rev. 0 of The OP and PQ phases of the process validation are not available for the bag moulding process and automatic assembly. Documents for packaging validation and DM shelf life are not available. Validation documents for gamma and steam sterilization processes are not available. DM10 rev. 02 feb-17 pagina 3 di 4

18 ITALCERT Istituto RRC DM STAGE 1 n 1062 STAGE 1 AUDIT REPORT CERTIFICATION ISO CERTIFICATION DIR. 93/42/EEC page 4 of 4 No. Ref. document Observation Technical File FT15 Rev. 0 of Technical File FT15 Rev. 0 of Evaluation Supplier PO39 Rev. 3 of FT15 Rev. 0 of Par. 6 PO25 Rev. 5 Of FT15 Rev. 0 Annex 6 Biocompatibility Report FT15 Rev. 0 del Drafts of the IFU and Label of Medical Device are not available. The identification and the qualification of supplier for the steam sterilization process is not available It is recommended to define the competences for the clinical evaluation functions in relation to the provisions of the MEDDEV Guideline Rev. 4, and to give evidence (eg curriculum) of the actual possession of the requisites by the resources concerned. The organization has foreseen to do (p. 2.10), the notification of incident to the ON, also identifying the social reason for detail, it is recommended to foresee all the ONs involved in the DM marking of DMs. The document, for the selection of the biocompatibility tests to be carried out, is conformed to the requirements of ISO but it considers only the "Blood bags" DM without considering additional components (e.g. needles) that are invasive and therefore that come into contact with the human body. It is necessary to assess the need for conducting product release tests and to justify the lack of need for risk management documentation. Section 8 IDENTIFICATION OF CRITIAL NON CONFORMITY ELEMENTS (documents, sampled during audit, that it would be classified as non conformity during audit of stage 2 if not managed them) No Description Section 9 IDENTIFICATION OF CRITAL ELEMENTS (Item that must be managed and solved before audit of stage 2) N. Description The General Manager or its representative to confirm that there are the autorizations to carry out activities related with object of certification Lead Auditor Vendramin Christian Organization DM10 rev. 02 feb-17 pagina 4 di 4