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At QNET, we provide comprehensive legal representation services tailored to the needs of medical device manufacturers entering and operating in the European Union (EU), the United Kingdom (UK), Switzerland, and the United States. Our services ensure compliance with regulatory frameworks, including the requirements for clinical investigations outlined in the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746).
Why Choose QNET as Your Legal Representative?
- EU Authorized Representative (EU MDR)
As your EU Authorized Representative, we act as the liaison between your company and EU authorities. We assist in ensuring compliance with all MDR requirements, including support for clinical investigations (MDR Articles 62-80). This includes reviewing and advising on the documentation necessary for clinical investigations, such as the clinical investigation plan, ethics committee approvals, and compliance with General Safety and Performance Requirements (GSPR). - UK Responsible Person (UKRP)
For manufacturers selling in the UK, we fulfill the role of UKRP, meeting the requirements of UK medical device regulations. This includes guidance on clinical investigation documentation needed for product approvals in the UK market. - Swiss Representative (CH-REP)
We navigate the Swiss regulatory framework, which closely aligns with MDR requirements. As your CH-REP, we ensure compliance with clinical investigation obligations and post-market surveillance activities. - US Agent Services
For non-US manufacturers seeking FDA compliance, we serve as your US Agent, facilitating communication with the FDA, including clinical trial requirements and premarket submissions.
Support for Clinical Investigations
Clinical investigations are crucial in demonstrating medical devices' safety, performance, and clinical benefits. As part of our legal representative services, we provide:
- Compliance Guidance: Ensuring clinical investigations meet MDR and IVDR requirements, including mandatory reporting, ethics committee reviews, and competent authority notifications.
- Documentation Review: Assistance in preparing and reviewing clinical investigation plans, investigator brochures, and patient information.
- Post-Investigation Support: Support in submitting clinical investigation reports and integrating findings into technical documentation.
- Regulatory Alignment: Ensuring alignment with MDR and IVDR General Safety and Performance Requirements (GSPR) and related clinical evaluation processes.
Our Distinctive Advantages
- In-House PRRC Expertise
Our team includes registered Persons Responsible for Regulatory Compliance (PRRC), ensuring that your clinical investigation documentation and post-market activities align with MDR and or IVDR requirements. - Global Reach, Local Expertise
With offices in the EU, UK, Switzerland, and the US, we offer localized expertise while maintaining a global perspective on regulatory compliance. - Tailored Solutions
We design customized strategies to fit your company's specific needs, ensuring smooth regulatory pathways and effective market entry.
What We Offer
- Regulatory representation and compliance monitoring.
- Clinical investigation guidance and documentation support.
- Technical documentation review and submission.
- Registration with relevant authorities.
- Post-market surveillance and vigilance reporting.
- Liaison services for audits and inspections.
- Expert advice on evolving regulatory landscapes.
Partner With QNET for Seamless Market Access
With years of experience and a proven track record in regulatory compliance, QNET is your trusted partner for navigating complex legal and regulatory requirements. Let us help you focus on innovation while we manage the regulatory landscape, including clinical investigation requirements for your products.
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Switzerland is already part way through transitioning to its own regulations due to the breakdown in its mutual recognition agreement with the EU at the end of May 2021.
The impact of the breakdown of the MRA is that Swiss manufacturers are now regarded as third-country companies in the EU. This means that Swiss manufacturers and those manufacturers who used Swiss notified bodies or authorized representatives must, therefore, have new certificates issued by EU notified bodies and have an authorized representative in an EU country.
In an update to the Swiss Medical Device Ordinance (MedDO), the Swiss equivalent of the EU Medical Device Regulation, published one week before the EU MDR was implemented on 26 May, three transition period deadlines were set for Swiss imports of CE-marked and labeled devices:
- 31 December 2021 for class III devices;
- 31 March 2022 for class II devices; and
- 31 July 2022 for class I devices.
After these dates, the continued export of devices into Switzerland by foreign manufacturers will be subject to their appointment of a local Swiss-based authorized representative (CH-REP), or use of their own local company in Switzerland, should they have one. This will necessitate product label changes.
Neither the UK nor Switzerland have access to, nor are part of, the Eudamed medical devices database.
QNET is in processing to open an local office in Switzerland to provide CH-REP services. Contact our office for more information.
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Amending Implementing Decision (EU) 2021/1182 regards harmonized standards for the biological evaluation of medical devices, sterilization of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer, processing of health care products and home light therapy equipment. See table.
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Standard |
Title |
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EN ISO 13485:2016/ A11:2021 |
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) EN ISO 13485:2016/A11:2021 |
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EN ISO 10993-23:2021 |
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021) |
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EN ISO 10993-9:2021 |
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019) |
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EN ISO 10993-12:2021 |
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021) |
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EN ISO 13408-6:2021 |
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021) |
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EN ISO 14160:2021 |
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020) |
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EN ISO 15223-1:2021 |
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021) |
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EN ISO 17664-1:2021 |
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021) |
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EN ISO 11737-1:2018 |
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018) EN ISO 11737-1:2018/A1:2021 |
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EN IEC 60601-2-83:2020 |
Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment EN IEC 60601-2-83:2020/A11:2021. |
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EN ISO 17511:2021 |
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples |