Prac+cali+es of CE technical file and quality system for medical so=ware

Transcription

1 Prac+cali+es Prac+cali+es CE technical file and quality system for medical so=ware Hans van Dulmen s it a Medical Device (MDD, AMD, VD)? What class Medical Device? Quality System constella+on No+fied Body interac+on The Project The Device Direc+ve requirements, standards, labelling Upload and maintenance in Appstore Device changes The Quality System s it a Medical Device Needs to meet defini+on Medical Device (likely MDD but can also be AMD or VD) as supplemented by EU guidance documents on MEDDEV 2.4/1 Classifica+on medical devices MEDDEV 2.1/6 Qualifica+on and Classifica+on stand alone so=ware in accordance with Na+onal guidelines d4 UK medical charity: Regula+on health apps: a prac+cal guide Swedisch Competent Authority: Proposal for guidelines regarding classifica+on so=ware based informa+on systems used in health care s it a Medical Device Needs to meet defini+on Medical Device (likely MDD but can also be AMD or VD) MDD: medical device means any instrument, apparatus, appliance, so=ware, material or other ar+cle, whether used alone or in combina+on, including the so=ware intended by its manufacturer to be used specifically for diagnos+c and/or therapeu+c purposes and necessary for its proper applica+on, intended by the manufacturer to be used for human beings for the purpose : diagnosis, preven+on, monitoring, treatment or allevia+on disease, diagnosis, monitoring, treatment, allevia+on or compensa+on for an injury or handicap, inves+ga+on, replacement or modifica+on the anatomy or a physiological process, control concep+on, and which does not achieve its principal intended ac+on in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its func+on by such means Stand alone so=ware is considered to be an ac+ve medical device. 1

2 s it a Medical Device EU guidance documents on MEDDEV 2.4/1 Classifica+on medical devices stand alone so=ware is considered to be an ac+ve medical device: Class a, Class b, Class (per classifica+on rule 9, 10, 11 or 12) b or not b MEDDEV 2.1/6 Qualifica+on and Classifica+on stand alone so=ware Recognizes the variety sw health care applica+ons; medical purpose and general purpose What Class Medical Device A=er having agreed consensus that it is a Medical Device (based on claims made and nature the device), classifica+on according to MEDDEV 2.4/1 Classifica+on medical devices shall be performed. Confirm this classifica+on with third party experts or No+fied Body! Class allows for self cer+fica+on Class a, b, require 1. the Tech File by the No+fied Body 2. the EN SO cer+fied Quality System Compensa+on for Visual mparement Medical Device? The Route to CE mark CONFORMTY ASSESSMENT PROCEDURE + CERTFCATES FOR AMD AND MDD b,a, an, b ANNEX 2 ANNEX 2 ANNEX 3 Type Examination Full Quality System Full Quality System Examination the b, a Design b, a Dossier b, a b, a Examination by Notified Body Technical File ANNEX 4 ANNEX 4 ANNEX 5 ANNEX 6 Statistical Production Product Quality Quality Evaluation and Evaluation and Surveillance Surveillance by the by the CE-Mark with dentification-number a, ANNEX 7 Self-certification with documentation available CE-Mark t s a Medical Device, so get acquainted with Essen+al Requirements Harmonized Standards So=ware lifecycle, usability, clinical evidence Change Control Control over subcontractors EU Language Requirements Associated Direc+ve Requirements Declara+on Manufacturer/Authorized Representa+ve Establishment Responsibili+es Compliance to Direc+ves Post Market Surveillance Communica+on to Competent Authori+es / No+fied Bodies Role Competent Authority 2

3 The Device t s so=ware so at a minimum the following medical direc+ve based standards apply STANDARDS EN 62304:2006 EN 62366:2008 EN SO 14971:2012 MEDDEV EN 980:2008 EN1041:2008 TTLE Medical device so=ware - So=ware life- cycle processes Medical devices Applica+on usability engineering tomedical devices Medical devices Applica+on risk management to medical devices CLNCAL EVALUATON: A GUDE FOR MANUFACTURERS AND NOTFED BODES Symbols for use in the labelling medical devices nforma+on supplied by the manufacturer with medical devices Project challenges What if App has already been (largely) built? What if App is already in the Appstore? What if the modelling per EN does not fit your process? What if you don t have the applica+on specific test facili+es (e.g. at hearing applica+ons, diabe+c control) s the usability data and clinical data mee+ng the expecta+ons? The FU <tbd> <any applica+on specific (harmonized) standard> Supplemented with the requirements the following regula+on / direc+ve: Regula+on 207/2012 on electronic instruc+ons for use medical devices Direc+ve 95/46/ on the processing personal data and on the free movement such data. Upload in Appstore Meet EU language requirements for medical devices How to implement recall mechanisms should App have a bug? Have user update App but what if user does not do? Do ios update affect the Technical File? The Quality System For Class devices the Quality System dimensions par+cularly focus on Change Control, Post Market Surveillance, communica+on to Competent Authori+es For Class a and Class b devices the manufacturer shall establish a (EN SO based) Quality System. 3

4 The EN SO based Quality System For Class a and Class b devices the manufacturer shall establish an (EN SO based) Quality System. This Quality System + the App designed and manufactured under that Quality System shall be audited by a No+fied Body. Audit on the Tech File Audit on the Quality System Selec+on process the No+fied Body Discuss with more than one No+fied Body Field Exper+se Select one the big ones The EN SO based Quality System Establish a Quality Manual plus a set SOP s, at a minimum dealing with Document Control Management Review Resource management nternal Audit Product Realiza+on Purchasing Change Control Complaint Management CAPA Risk Management Training Clinical Evalua+on Usability Calibra+on and Maintenance The EN SO based Quality System Establish a Quality System is a significant project (start from scratch: months) which is only successfull if implemented if it benefits the company rather than being set up to meet regulatory requirements. Audit on the Tech File resulted in CE cer+ficate Audit on the Quality System resulted in Annex and EN SO cer+ficate Yet, this is not the end, it is the beginning Address changes in product, changes in regula+ons in Tech File (and communicate to No+fied Body as required) Ac+vely implement Post Market Surveillance Con+nues training employees on regulated environment 4

5 Ques+ons? 5