The EU Medical Device Regulation (MDR) was published in the Official Journal of the European Union on May 5, 2017 and became the current regulatory standard on May 26, 2021. The EU MDR replaces the Medical Device Directive (MDD) [93/42/EEC] and the Active Implant Medical Devices Directive (AIMD) [90/385/EEC].
The Transition Period began in 2017 for medical device manufacturers selling medical devices into Europe and continues today based on the medical device class for each regulatory submission. Regulatory Compliance Associates® can assist clients that need to comply with the EU MDR requirements with the following services:
Transition to EU MDR Compliance
1. Perform a Comprehensive Review of Entire Product Portfolio and Current Certificate Expiry Dates
- Review and Assess the Client’s entire Product Portfolio including its:
- Legacy Products [CE marked devices under the Medical Device Directives (MDD) 93/42/EEC or the Active Implantable Medical Device Directive (AIMD) 90/385/EEC];
- Modified Legacy Products; and/or
- New Products currently in the Design/Development Phase.
- Confirm whether any Legacy Products and/or Modified Legacy Products have been affected by the new MDR Definitions and/or Reclassification of certain types of products into higher risk classes of devices;
- Reassess current classification of devices based on MDR Classification Rules;
- Prepare Product Rationalization Strategy Reports for Legacy Products, Modified Legacy Products, and New Products (as appropriate and applicable). which may assist the Client in making internal decisions about whether to maintain and/or bring such products in compliance with the MDR;
2. Staff Augmentation and Support
- Readiness Audits / Pre-Certification Audits and/or Assessments
3. Perform a Gap Assessment of the current Quality Management System (QMS) and its Current Processes and Procedures for MDR Compliance.
- Review and Assess the Quality Management System (QMS) requirements including all current policies, processes, and procedures against ISO 13485:2016 requirements
- Technical Documentation requirements
- Labeling requirements (including required languages in each Member States)
- Unique Device Identification (UDI) System
- Data entered into the EUDAMED Database per Article 33
- Risk Management System (RMS)
- Risk Management Plan and Report for each device
- Clinical Data Requirements
- Data Integrity Best Practices
- Safety and Performance Requirements
- Post-Market Surveillance System (PMS)
- Vigilance Activities
- Market Surveillance Activities
- Requirements regarding Design and Manufacture of Devices per MDR requirements
4. Remediation and Implementation of EU MDR Compliance Plan
- Supply Chain Requirements
- Development and Implementation of Compliance Plan for systems and devices
- Remediation of EU MDR Compliance Gaps noted during Assessment
- Development and Implementation of EUDAMED Database compliance plan for all of the following six pillars of the EUDAMED
- Actor Registration
- Unique Device Identification
- Clinical Investigation
Regulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:
- Life Sciences
- Biologic & Biotechnology
- Sterile compounding
- Medical device
- Lab Testing
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
About Sotera Health
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.
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