Medical Device Directive

Medical Device Directive WG9 - IEC/SC 62A ISO/TC 184/SC 2 Joint Working Group 9 Saeed Zahedi 4 th of July 2012 Blatchford Copyright 2012 Commercial in confidence

Definition and Requirements MDD is law, Operating Rules for manufacturers Mitigation of all risks to User / Patient Addition to MDD in 2010, and FDA Guides # 1 Essential Requirements 16 of them Use of Harmonized Published Medical EN/ISO Structural, Functional testing and Clinical Trial Technical File, Traceability, Vigilant System Labelling Packaging and Fitting Instruction Medical Devices Quality Standard ISO 13485

MDD CE Compliance Process Relevant Medical Standards MDD 2007 MDD ER Annexes Risk Assessment 14971 Quality Assurance 13485 Software assessment IEC 62304 Clinical Evaluation 14155 Electrical Safety IEC 60601 US Specific FCC CFR47 Structural Safety 22523 Robotic Standards 13482 Information Supplied 1041 Labeling Requirement 980 Infection Microbial 11135 Bio Compat. 10993

Creation of Technical File Classification 1 2a 2b 3 Approved Test and Trial Product Specification Technical File Design Intend Controlled Inspection Post Market Surveillance ER Check List

Safest route for manufacturer User Safety Rouge Product Level field Protecting user Reduce Litigation Declaration of Conformity ISO 13485 Audit CE Policing Vigilant System e.g. MHRA Competent Authority Registration Notified Body

Integrating Different Skill set Cross Reference to ER of MDD Cover all Requirements with EN standards Definition is it a medical device Is it Class 1 for self certify Is it Class 2a and above Notified body help General MDD ER fulfilment Risk Assessment for medical devices Clinical Trial and Tests to mitigate Risk Medical Quality Assurance certification

Example: Exo Leg CE Marking Determine is it a Medical Device Determine are we the Manufacturer Determine Which Class of Medical Device Start the Process of MDD Compliance End by Setting up Vigilant System Certify CE Declaration of Conformity Start Post Market Surveillance Process Plan the Exo Leg II

Department of Health Guidelines

Example: Exo Leg Meeting ER I. GENERAL REQUIREMENTS ER A - N/A Applied DOCUMENT Specifications, REFERENCES AND Standards, LOCATION Procedures, with Justification M5 1. The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health f h li bl h A QA manuals and procedures This shall include: BS EN 14971:2007 reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which consideration of the technical knowledge, experience, education and training and where applicable the medical (Risk management) Design History File. Regulatory Guidance A risk assessment according to the relevant harmonised standard should be performed Risk Management report, labelling, Production specification in the Technical File User manual

Revised MDD and Software and Evidence of Benefit Item CLA SS CEI IEC 62304 compliance checklist 4 General requirements 4.1 Quality management systems 4.2 Risk Management, application of risk management according to ISO 14971 4.3 Software safety classification 5 Software development process 5.1 Software development planning 5.1.1 A,B,C Software development plan 5.1.2 A,B,C Keep software development plan updated 5.1.3 A,B,C Software development plan reference to SYSTEM design and development 5.1.4 C Software development standards, methods and tools planning 5.1.5 B,C Software integration and integration testing planning 5.1.6 A,B,C Software verification planning 5.1.7 A,B,C Software risk management planning 5.1.8 A,B,C Documentation planning 5.1.9 A,B,C Software configuration management planning 5.1.10 B,C Supporting items to controlled 5.1.11 B,C Software configuration item control before verification 5.2 Software requirements analysis 5.2.1 A,B,C Define and document software requirements from system requirements 5.2.2 A,B,C Software requirements content 5.2.3 B,C Include risk control measures in software requirements 5.2.4 A,B,C Re-evaluate medical device risk analysis 5.2.5 A,B,C Update system requirements 5.2.6 A,B,C Verify software requirements 5.3 Software architectural design

Example: Declaration of Conformity - CE Marking

Typical Approach Demonstration Excel representation in addition to FMEA Demo on Screen example Exo leg