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Your Global Quality Assessor for Medical Devices
Your Global Quality Assessor for Medical Devices

LNE G-MED's posts

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Control of Critical Suppliers for Medical Devices: ISO 13485:2016 perspectives

The ISO 13485 standard represents a Quality Management System base for many regulatory schemes.

With the recent publication of the new Medical Device and In Vitro Diagnostic Regulations, the regulatory framework surrounding Medical Devices evolves and re-enforces the control of external parties (Suppliers, Subcontractors).

The newest revision of the ISO 13485 standard published in March 2016 aims in the very same direction.

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Free Webinar - Control of Critical Suppliers for Medical Devices: ISO 13485:2016 perspectives

The publication of ISO 13485:2016 in March last year reinforced the notion of control of supply chain for Medical Device manufacturers. With a clear reinforcement of the risk-based approach in the entire ISO 13485:2016, it is no exception that the Purchasing section (7.4) includes new provisions to strengthen Supplier control. Requirements are mostly written towards the medical devices legal manufacturer to control its suppliers, however it is critical that suppliers are also aware about them as they could also be ISO 13485 certified. The updated standard gives more details about what companies shall consider in the process of evaluation, selection and monitoring of their suppliers. It not only amends the management of Supplier relationships, but also puts in perspective the whole process of supplier selection.

Join LNE/G-MED and Florianne Torset-Bonfillou, Director of Regulatory, Education and Quality at LNE/G-MED North America, Inc., to understand why Notified Bodies need to ensure control of Critical suppliers by Medical Device manufacturers, how ISO 13485:2016 impacts Critical Suppliers’ processes. You can tune to LNE/G-MED North America’s upcoming free webinar on Critical Suppliers for Medical Devices: ISO 13485:2016 perspectives.

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The Medical and In Vitro Diagnostic Medical Devices regulations (MDR and IVDR) have been published on May 5th, 2017 in the Official Journal.

The date of entry into force for the new regulations on Medical and In Vitro Diagnostic Medical Devices (MDR and IVDR) is May 25th, 2017.

The transitional period will officially start right after the entry into force.

The transition to the EU Medical Device Regulation (MDR) will last 3 years; with 2020 as the application date. The In Vitro Diagnostic Regulation (IVDR) will have a longer transition period, set to last 5 years with 2022 as the date of application.

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The #MedicalDevice and In Vitro Diagnostic Regulations (#MDR and #IVDR): Changes and Impacts (#euparliament, #notifiedbody).

The Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) were initially proposed in 2008 when the EU Commission triggered a consultation on the community’s existing requirements covering medical devices. The plan was 1st released by the commission in 2012 to modify the EU’s medical device regulatory framework along with a proposed regulation replacing the EU’s current Medical Device Directive 93/42/EEC, the EU’s directive on Active Implantable Medical Device 90/385/EEC, and the In Vitro Diagnostic Directive 98/79/EEC.

For the Medical Device Regulation (MDR), this regulation aims to ensure the smooth functioning of the internal market in regard Medical Devices, taking as a base a high level of protection of health for patients and users. At the same time, this regulation sets high standards of Quality and Safety for Medical Devices in order to meet common Safety concerns as regards such products.

For the In Vitro Diagnostics Regulation (IVDR), the decision to regulate In Vitro Diagnostic devices through a regulation as opposed to a Directive will avoid differences in national interpretation that can lead to uneven implementation of the Directive. This will also strengthen Patient Safety through the introduction of more stringent procedures for Conformity Assessment, Post-Market Surveillance and through requirements to generate Clinical Data providing Evidence on Safety, Performance and any Undesirable side-effects. This should also allow rapid and cost-efficient market access for Innovative Medical Devices.

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The new IVDR and MDR adopted by the EU Parliament

What began in 2012 at the initiative of the European Commission came to an end during the plenary session of April 5th, 2017, with the adoption by the European Parliament of the new regulations on Medical and In Vitro Diagnostic Medical Devices (MDR and IVDR).

Team NB, the European Association for Medical devices of Notified Bodies, in a note recently published on their website offers a sneak peek of the atmosphere surrounding the session: “There were for each text only one amendment tabled by Nigel Farage and the UKIP, was submitted, asking to reject the trilogue results. These amendments were rejected, which from a procedure point of view is a final endorsement of the text agreed by the Council in March and a closure of the second reading”. This was later confirmed by the acting European Parliament President Rainer Wieland.

In its Press release, the European Commission “welcomes the adoption of its proposal for two Regulations on medical devices which establish a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety.”

The changes introduced by the new regulations focus on the following areas:

- Improve the quality, safety and reliability of medical devices
- Strengthen transparency of information for consumers
- Enhance vigilance and market surveillance

The final publication in the Official Journal for both regulations is expected within 4 to 6 weeks.

For Medical Device manufacturers, the adoption of the Medical Device Regulation (MDR) is a reminder that the transition will begin soon and last for 3 years; taking full effect by 2020. LNE/G-MED, a frontrunner for the designation under the new MDR and IVDR, will dedicate its next webinar to the changes introduced by both regulations. Stay tuned!

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Free Webinar: The #medicaldevice and #IVD #regulation Key changes, transition and impacts for Medical Device #manufacturer

Join us on Wednesday, April 26th, 2017, 2 PM EDT as LNE/G-MED North America Inc. will be hosting a free informative session on the Medical Device and In Vitro Diagnostic regulations, the common changes and timelines introduced by the regulations, and what impact can manufacturers expect.

The origin of the proposed regulations dates back to 2008: The Medical Device Regulation and the In Vitro Diagnostics Regulation were initially proposed in 2008 when the EU commission triggered a consultation on the community’s existing requirements covering medical devices.

The final publication for both regulations is expected for no later than May 2017. Manufacturers will phase out from the respective directives governing their currently approved medical devices through a transition period of three years and fully embrace the requirements of the MDR, which will take full effect in 2020.The same is expected for In Vitro Diagnostic Medical Device Manufacturers with a transition period of 5 years, and the IVDR becoming enforceable by the end of 2022.


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Notification of changes: How, what and when to communicate with your Notified Body

The Medical Device Industry has always been one of the most demanding when it comes to satisfying its stakeholders.
Satisfying and embracing the needs of multiple actors (market evolution, patient safety, investors, regulators and supply chains) has obligated Legal Manufacturers of medical devices to adapt to change in order to remain viable and in demand.

Nowadays, we see that the frequency of change has picked up and the impact can be considerably stronger.
Many medical device manufacturers have been alternating suppliers and subcontractors to meet their supply or quality needs. Others are analyzing the upcoming changes of regulations and standards (MDSAP, MDR and IVDR, ISO 13485…etc.) to prepare for a smooth transition and safe landing. Some are looking to consolidate sites and activities while others are adopting new technologies (3D printing, cloud data management, nanotechnology…etc.).

With all of the above moving targets, communication and involvement of all interested parties is crucial. Today we will focus on one communication aspect that can make or break a medical devices successful journey to market…..that is the Change Notification to your Notified Body. LNE/G-MED in this edition of the March newsletter touches on the common changes that need to be communicated to your Notified Body and when the change or change plan should ideally be communicated.

Read more:

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Final version of the EU Medical Device and In Vitro Diagnostic Regulations: Let the vote begin!

The Council of the European Union announced the publication on Wednesday February 22nd, 2017 of the final draft version for the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Both texts, respectively 566 pages and 477 pages, have been long-awaited and are now available for consultation.

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