How Are You Tracking Your EU MDR Compliance?
Do you have a complete checklist?
Okay, so your medical device company got a reprieve. The corrigendum vote by the EU pushed off MDR compliance until 2024. Big sigh of relief.
Now what?
You still have a big, steamy pile of...technical documentation and you still have no way of knowing if your company is EU MDR compliant. Where do you start?
Other than some labeling changes and CMR assessments (substances that are carcinogenic, mutagenic, toxic to reproduction...basically hazardous materials), your fundamental base for being EU MDR compliant is still your Design History File (or Technical File). Sure there are some added rules, but by and large your deliverables will still be the DHF.
So the question now is: Do you have a full, complete, and comprehensive listing of all deliverables for your Technical File to be in compliance? Chances are...no.
Why?
Most companies fall into the “traditional engineering†trap of “we’ve always done it this way; why do we need to have this?†Aside from the obvious answer of being able to send product to market in the EU, there’s the larger question of being ready for Notified Body audits. We have found over the last couple of months, the NBs are focusing on Technical Files and CMRs quite heavily.
If you don’t know that you’re MDR compliant, chances are you aren’t.
The Deliverables
First, to understand what is on this checklist, one must first understand what the list is. For all intents and purposes, your checklist starts as a complete listing of all activities needed for a DHF, because – like all products – at some point in time you will be producing a new product from scratch.
If you already have a product on the market, there’s still no guarantee that the product is compliant without some way of checking to see that the Technical File is complete. Below is a full and vetted listing of all deliverables for a complete DHF (Technical File) that is 13485- and EU MDR-compliant.
1 Phase 1 - Design and Development Planning 2 Technical Documentation a. General Device Information b. Intended Purpose and User c. Basic-UDI d. Patient Population and Medical Conditions e. Principles of Operation (Interoperability/Compatibility) f. Device Declaration g. Risk Classification and Justification h. Novel Features i. Lifetime of the Device Assessment, Obsolescence Plan, Lifespan Manual j. Accessories k. List of Configurations/Variants l. Key Functional Elements m. Raw Materials n. Software o. Overview of previous generations p. Similar devices available 3 Feasibility Assessments a. Regulatory Assessment b. Quality Assessment (SQE, QA, etc.) c. R&D Assessment d. Marketing Assessment e. Purchasing Assessment f. Distribution Assessment g. Sustaining Engineering Assessment h. Operations Assessment i. Finance Assessment j. Legal Assessment (IP) 4 Program Management Plan (PMP) a. Project Charter b. Project Team c. Project Resources d. Design Stages Used e. Manufacturer legal information f. Organizational structure g. Responsibilities h. Manufacturing and Packaging Processes i. Authorized Representative j. Single Registration Number (SRN) 5 Clinical Evaluation Plan (Class I) a. Define Scope, generate CEP, and decide whether clinical investigation is required b. Clinical Evaluation Plan w Risk c. Clinical Follow-up Plan (All Classes) 6 Post-Market Surveillance Plan 7 Initial Hazard Assessment/Risk Analysis 8 Quality Plan 9 Regulatory a. Regulatory Plan/Strategy b. Standards Applicability Report Draft 10 Risk Management a. Risk Management Plan b. Tracking and Trending of Incidents c. Reportability of Incidents d. Benefit:Risk Analysis 11 Market Launch Plan 12 Field Service Customer Support Plan 13 Design Inputs a. Technical Inputs, VOC, Human Factors, Design, UR b. GSPR, Essential Requirements c. Traceability Matrix Initiated 14 Phase 1 - Design and Development Planning Review 15 Phase 2 - Product Development 16 Product Technical Specifications (features, outputs, dimensions, drawings, performance attributes) 17 SW Development Plan 18 dFMEA 19 Product Labeling a. Device Labels b. Packaging Labels c. IFUs Draft d. Promotional Materials (incl. Ordering Info) e. Surgical Technique and Ordering Information f. Implant card 20 Prototype Units/Lots Plan/Execution/Control 21 Project (Operations/Manufacturing) Plan 22 Design Verification Plan 23 Worst Case Test Criteria Established via ETR 24 Configuration Management of Design 25 Design Verification Test Summary Report 26 Quality Control Processes 27 Design Validation Test Plan 28 Process Validation Protocols 29 Manufacturing Development a. Device Master Records b. pFMEAs c. DHRs (Batch Records, Work orders, etc.) d. Manufacturing Documents (SOPs, WIs, Forms, BOMs) e. Pilot Build(s) f. Build Test Samples, Prelim simulated use testing g. Design Outputs established and in I-O Matrix h. Biological safety risk assessment plan i. Usability Engineering File Completed j. Stability Studies including Shelf Life k. Sterilization Testing l. Packaging/Transportation Testing m. Functional/Chemical Testing n. Performance and Safety Testing 30 Suppliers/Vendors a. Approved Supplier's List b. Supplier/Vendor Qualifications c. Supplier/Vendor Agreements d. External Supplier CMR Assessments e. Supplier Production Process Approval (SPPA) f. Process Flowcharts g. Mfg/Pkg Specifications/Drawings Completed (SMS) h. CMRs in Contact Materials Confirmed/Rationalized i. Complete Part Number Listing 31 Phase 2 - Product Development Review 32 Phase 3 - Design VnV, Qualifications 33 Approved Parts Listing, Component Qualification, Materials Evaluation Summary 34 Design Outputs Summary Reports 35 Reports, Action Items a. Sterilization Report and Procedures b. Packaging, Transportation Testing Report c. Cleaning Report and Procedures d. Biocompatibility Report e. Biomechanical/Functional/Chemical Testing Report f. Traceability Matrix Completed (DIOT) g. MRI Compatibility Validation/Adoption Report h. Electr Safety and Electromag Compatibility Report i. VnV Memo of Equivalence j. Biological Safety Risk Report k. Reg Strategy, Eng Drawings sent to trade compliances l. IMTE in place and calibrated m. EU MDR GSPR DD2888 Complete n. SW VnV Report o. Reprocessing Summary/Report/Validation Other 36 Service Manual 37 Installation Verification Testing (Equipment) 38 Product Storage and Handling Requirements 39 Quality Control Processes Report a. Quality Controls Used b. Validations Completed c. Monitoring Summary d. List of Mfg Sites e. Final Inspections Used for Product(s) 40 Label Translations 41 Phase 3 - Design VnV, Qualifications Review 42 Phase 4 - Transfer Design to Manufacturing 43 Design Transferred to Manufacturing/Training 44 Final Documentation for File a. Pre-Clinical/Clinical Data Evaluation Report b. Risk Management File (Plan, Hazards Assessment, Risk Control, Report & Solutions Adopted) c. Post-Market Surveillance Report (Class I) d. Periodic Safety Update Report (Class IIa, IIb, III) e. Post-Market Clinical Follow-up Report f. Surgical Technique and Ordering Information g. Summary of Safety & Clinical Performance (SSCP, Class III and Implantables) h. Marketing History of Device i. Relevant Regulatory Approvals j. Standards Applicability Report FINAL k. IFU Final l. Device Master Record Index m. Product Training for Sales, Customer Service, etc. n. ERP System Elements Established o. IP Review Complete p. GUDID Submission Complete q. 801 & 802 Requirements Complete r. Product Pricing Established s. Alpha Launch Plan complete t. EU QMS Certificate u. EU Techn Doc Assessment Certificate 45 MDR Tech File Compiled EU Declaration of Conformity (DoC) 46 DHF Complete 46 47 Phase 4 - Transfer Design to Manufacturing Review
One will notice that in addition to having a straight listing of all deliverables, these elements are also placed in a Design Phases approach, in line with Design Controls. Obviously this list cannot go into the requirements for satisfying each element. That’s going to take some work reading the EU MDR and understanding what is being asked of each element; however, at least this checklist is a way to determine if all elements are being considered.
I realize that not all companies use the "Phase Gate" approach to developing medical device products and many have different elements in the different phases. Suffice it to say, no matter how you chop, slice and organize your technical files, the elements will remain the same.
Hope this starts to help all you going through the grueling task of MDR conversion.
Mark Proulx has been working in the Medical Device and Pharmaceutical industries for close to 30 years. His company, MLB Marketing, has been involved in building Quality Management Systems from scratch for small companies and been integral in major remediation projects for multi-billion dollar, multi-national corporations like Johnson and Johnson, Philips, Medtronic, Depuy-Synthes, Teleflex, Zimmer-Biomet, and Ethicon. He can be reached at: mlbmarketing@icloud.com for questions, comments, and suggestions.