The EU Medical Device Directive has been replaced by the Medical Device Regulation. Ready?

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What's in the toolkit?


MDR Documentation Submissions: Best Practices Guidelines

The two most frequent reasons for delays to technical documentation reviews are:
- BSI has not been provided with all of the information needed for the review
- The information is present within the technical documentation, but is difficult to locate
To reduce the frequency of the above issues, BSI Medical Devices Group proposes this guidance, informally known as “MDR Documentation Submissions: Best Practices Guideline."


Symbols to be used on medical device labeling and manufacturer-provided information for ISO 15223/20417

This webinar reviews the status and updates for both ISO 15223 and ISO 20417 on EU medical device/in vitro device labeling/identification requirements including new symbols and definitions. Explores new level of detail and areas such as required information elements, scope and references.


Medical Devices Regulation(MDR) Mapping Guide

A guide to help you to map the MDR General Safety and Performance Requirements (GSPRs) to the Essential Requirements for Medical Device Directive (MDD), and Active Implantable Medical Device Directive (AIMD). The document also lists other relevant information which can help you in planning your transition to the MDR.


Exploring MDR Article 120, Clause 3

An examination of what medical device manufacturers need to think about in the remaining time before MDR implementation to meet the requirements of Article 120, Clause 3. This webinar covers the more significant changes in the sections covering design, intended purpose, post-market surveillance, vigilance, economic-operator registration and device registration.


Medical device risk management and the new ISO 14971

ISO 14971 provides a complete and comprehensive process for manufacturers to identify hazards associated with the medical devices under development and throughout the life cycle of the medical device. This whitepaper explores the requirements in the third edition of ISO 14971 that are aligned with the general safety and performance requirements of the European Regulations MDR and IVDR and are in accordance with the regulatory requirements for medical devices in most other jurisdictions.


MDR – what we currently know

In this webinar Dr Suzanne Halliday, Regulatory Director and Head of Notified Body for BSI, and Dr Jayanth Katta, Regulatory Lead for the BSI UK Notified Body, talk about what we currently understand about the MDR Date of Application; the latest on the rolling plan of the Commission and implementation priorities including what happens in the absence of EUDAMED; and BSI learnings from initial audits and our recommendation to manufacturers to still prioritize their MDR work.

Are you ready for the EU Medical Device Regulation?

What is the plan for implementation of the MDR?

*Note: the blocks display the time period within which a certificate type can be valid, not the period of validity for a single certificate.

The new European Medical Devices Regulation entered into force on May 25th 2017, marking the start of the transition period for manufacturers selling medical devices into Europe. The new regulation will take effect May 26, 2021.

The MDR, replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), and has an updated transition period of four years. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements. Article 120 of the Regulation states a number of transitional provisions, and should be referred to for more detail.

Will the new requirements be enforced retrospectively?

No, the new requirements will be applied to all devices only when they are to be certified under MDR. After the transition period, devices not conforming to the MDR will need to be removed from the market.

The BSI Medical Device mission:
To ensure patient safety while supporting timely access to advanced medical device technology

We strive to set the global standard in thorough, responsive, robust conformity assessments, evaluations, and certifications.

BSI Group equips businesses with the necessary solutions to turn standards of best practice into habits of excellence. From assessment, certification and training to software solutions, advisory services and supply chain intelligence*, BSI provides the full solution to facilitate business improvement and helps clients drive performance, manage risk and grow sustainably.

For organizations large and small, BSI enables resilience by embedding excellence to create relevant, safer and more secure products/services leveraging the passion and expertise of our people. Renowned for its marks of excellence, BSI’s influence spans across multiple sectors with a particular focus on Aerospace, Automotive, Built Environment, Food, Retail, Healthcare and IT.

* If an organization is certified with BSI to a management system, please note that BSI will not provide consulting services for that particular management system due to impartiality requirements.

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