EU MDR Compliance
For Medical Device Manufacturers
GreenSoft provides the critical substance data you need to comply with the EU Medical Device Regulation (EU MDR) through our expert supply chain data collection, validation, and compliance software solutions.
サプライチェーン
データ収集
Regulatory
Screening
Compliance
モニタリング
プロジェクト
経営
Navigating Strict EU MDR Requirements
Mandatory since May 2021, the EU Medical Device Regulation (MDR) imposes strict rules on medical devices sold in the EU. Manufacturers must verify that their products do not exceed 0.1% w/w of carcinogenic, mutagenic, or toxic for reproduction (CMR 1A/1B) substances or endocrine-disrupting substances (EDS) without justification. Latex and substances of human or animal origin must also be disclosed.
Meeting these requirements demands extensive supply chain data collection and analysis — a complex, resource-intensive task.
当社は、お客様のためにサプライチェーンデータを収集いたします
We contact your suppliers directly to collect data on the presence of EU MDR regulated substances in your products and provide the data you need for submission to the UDI database and evaluation by a notified body for approval.
Hands-On Data Collection & Validation
We collect and validate detailed substance data from your suppliers, including animal- and human-derived materials.
Regulatory Screening
Using GreenData Manager (GDM) software, we cross-check your product data against the list of CMR 1A/1B and EDS substances restricted under EU MDR.
Compliance Monitoring
We monitor regulatory updates and notify you of changes affecting your products.
専門的なプロジェクト管理
A dedicated Project Manager is assigned to your project to provide bi-weekly status updates and keep your project on track.
データシート
Simplifying Substance Data Collection with GreenSoft’s EU MDR Solution
GreenSoft's EU MDR solution provides the substance data you need for submission to the UDI database and evaluation by a notified body for approval, freeing you up to focus on other elements of the approval process.
A New Standard for Medical Device Compliance
Published in 2017, the EU Medical Device Regulation (MDR) replaced the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive.
EU MDR changed how medical devices are defined and how devices are classified for risk, created a new labeling system, and includes substance content requirements.
なぜGreenSoftを選ぶべきなのか？
A Trusted Partner for Medical Device Manufacturers
With over 20 years of experience, GreenSoft supports medical device manufacturers of all sizes. We have expertise in active and passive components, electrical and mechanical parts, packaging, and raw materials.
Fast & Reliable Data Collection
Our extensive component database of over 97 million parts allows us to streamline the data collection process. By analyzing your BOM or parts list, we quickly identify components with existing validated compliance data, reducing time spent on supplier outreach.
実地調査によるデータ収集により、最高品質のデータを提供します
At GreenSoftでは、 当社のデータチームの担当者が、お客様の サプライヤーに直接連絡し 、完全かつ正確なデータを収集できるよう、必要な回数だけフォローアップを行います。 完全かつ正確なデータを収集するまで、何度でもフォローアップを行います。この手作業による確認プロセスを と自動化されたプロセスを組み合わせることで、 より データの品質と、プロジェクトの完了率の向上を。
Ready to simplify your EU MDR reporting process?
Manage MDR Data with GreenData Manager
EU MDR is one of 27 Environmental Regulations included in GreenData Manager® (GDM), the premier software solution for compliance data management, storage, and reporting.
Store and manage all MDR data collected from your suppliers in one place.
企業レベル、製品ファミリーレベル、または製品レベルで、コンプライアンスレポートを簡単に作成できます。
既存のPLMやERPシステムとシームレスに連携します。
あらゆる規制に対応できる、御社専用の材料データベースを作成してください。
EU MDR Resources
DATA SHEET
Compliance Data Services for the EU MDR
GreenSoft's EU MDR solution provides the substance data you need to enable your product to be submitted to the UDI database and evaluated by a notified body for approval, freeing you up to focus on other elements of the approval process.
動画
Substance Requirements of the EU Medical Device Regulation (EU MDR)
Learn about the various substance and labelling requirements affecting medical device manufacturers under the EU Medical Device Regulation (EU MDR).
WHITE PAPER
Environmental Compliance Data Services
Collecting environmental compliance information is a tedious and resource intensive process. GreenSoft offers a better way to complete the data collection and verification that is needed to comply with required regulations.
