technical documentation and medical device regulation

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The new European Medical Device Regulation (MDR) officially came into effect in May 2017 The regulation has consolidated two existing legal provisions and replaced both the current Medical Device Directive (93/42/EEC) and the Active Implantable Medical Device Directive (90/385/EEC) The European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are certainly no exceptions These new laws are a big win for patients But for medical device manufacturers they present significant new requirements in labeling and overall product transparency Here are some of the top questions we're hearing about MDR and IVDR and our expert answers

European Medical Device Regulation (EU MDR)

The new regulatory initiative falls under the EU Medical Device Regulation (MDR) and supersedes the Medical Device Directive (MDD) which previously had no provisions on traceability of medical devices so the steps necessary for compliance are completely new for organizations selling products in the EU market How We Help Clients Get Ready for EU MDR As the May 2020 deadline to comply with

For CE marking of a medical device the Medical Device Regulation requires that technical documentation is created and maintained The technical documentation is required for all classes of medical devices Our services include: Review of existing documents Compilation of the technical documentation Evidence of compliance with the Essential Requirements Implementation and documentation

Devices in full compliance with the current Medical Device Directive (MDD) that are either (1) reusable surgical instruments (2) in sterile conditions or (3) have a measuring function may remain or be placed on the market until May 26 2024 The delay will give manufacturers of these devices extra time to prepare their technical documentation before undergoing notified body review The

The European Union's proposed medical device regulation (MDR) will soon replace the EU's Medical Device Directive (93/42/EEC) and the Directive on active implantable medical devices (90/385/EEC) and is likely to result in important changes for medical device manufacturers

Technical documentation — sometimes called a technical file technical construction file or technical dossier depending on the regulation in question — provides a level of added scrutiny allowing companies in scope of these regulations to demonstrate their compliance

Understanding the Medical Device Regulation

To maintain patient safety the EU introduced the Medical Device Regulation (MDR) transforming and modernising the older Directives Whether you are new to regulatory affairs the MDR or are branching out from other areas of the wider medical device industry this fundamental-level course will detail the EU regulatory requirements throughout the

Since the 1990s regulation of the medical device industry in Europe has been relatively unchanged However recent incidents including the breast implant crisis and the hip replacements have now prompted urgent regulatory and compliance reforms to the industry Among the most significant of these are the European Commission's 2012 proposals for regulation on medical devices (EU MDR) and

Class III medical devices technical documentation instructions for use coronary stent hip implant silver-containing wound dressing RIVM report 360050021 3 supply if requested a standardized set of documentary evidence that their medical device conforms to regulatory requirements which is adequate for the purposes of all regulatory

Summary Technical Documentation (STED): a summary of technical documentation held for conformity assessment purposes Technical File/Technical Documentation: documentation required to assess conformity of the medical device with the regulations Essential Principles: Essential Principles of Safety and Performance of Medical Devices

Technical Documentation and Medical Device Regulation that have previously been placed on the market this includes but is not limited to the PMCF data vigilance data user feedback and complaints Based on these post-market data new inputs may trigger a novel cycle in

Medical devices are products or equipment intended generally for a medical use and are regulated at Member State level The Medical Devices and the In-Vitro Diagnostic Devices Regulations have introduced new responsibilities for the European Medicines Agency (EMA) and national competent authorities in the assessment of certain categories of medical device

Medical Device Validation Regulation Classification 3 1 For custom-made devices documentation indicating manufacturing site(s) and allowing an understanding of the design any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i)

Stakeholders in the medical device manufacturing sector listen up: The European Medical Device Regulation (MDR) is a new set of rules that govern the production and distribution of medical devices in Europe—and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace If your company was already compliant with the

Therapeutic Goods (Medical Devices) Amendment (In Vitro

(1) This regulation applies in relation to a transitional device that is a Class 1 in‑house IVD medical device Class 2 in‑house IVD medical device or Class 3 in‑house IVD medical device (2) Subject to subregulations (3) and (4) the amendments made by Part 2 of Schedule 1 to the 2015 Amendment Regulations apply in relation to the device for all purposes on and after 1 July 2017

The Medical Device Design History File Technical File / Design Dossier 17 April 2017 John He specializes in medical device CGMPs / systems / SOPs product to market defect and cycle time reduction equipment / process / product / software documentation / validation quality/regulatory Medical Device Regulation (MDR)

Only medical device companies that are in compliance with the new Medical Device Regulation (MDR) 2017-745 will stay in the European market after 26-May-2020 It's key to understand the gaps with the previous Medical Device Directive (MDD) 93/42/EEC and how to remediate them to continue business in the 2nd (about 30 % worldwide volume) worldwide medical device market

Technical File/Technical Documentation: documentation required to assess conformity of the medical device with the regulations Essential Principles: Essential Principles of Safety and Performance of Medical Devices MDCO: Medical Device

CE marking is the evidence that a medical device satisfies the ESR (essential safety requirements) of all relevant European Medical Device Directives and Regulations The CE mark is a binding legal condition to distribute a medical device in the EU market ECM is a Notified Body under the Medical Device Directives (MDD) with consolidated technical expertise and experience to provide smooth

20-7-2015ISO/DTR 80002–2 Medical device software – Part 2: Validation of software for regulated processes is a technical report under development which considers embedded and associated software with all medical devices IEC/TR 80002–1:2009 Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software

Technical documentation on post-market surveillance The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with Articles 83 to 86 shall be presented in a clear organised readily searchable and unambiguous manner and shall include in particular the elements described in this Annex 1 1

6 DOCUMENTATION AND RECORD KEEPING 14 7 MEDICAL DEVICE RECEIPT STORAGE AND SUPPLY 15 7 1 Introduction of a new medical device 15 7 2 Placing devices into saleable stock 16 7 3 Traceability 17 7 4 Storage 18 7 5 Pest control 19 7 6 Medical device disposal 19