In vitro diagnostics (IVDs) are medical devices that are regulated in their own regulation due to their special nature. In Switzerland, this has been the Ordinance on In Vitro Diagnostic Medical Devices (IvDO, SR 812.219) since May 2022, while the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) applies throughout the EU.At Metecon, you will receive in-depth advice and support in the field of in vitro diagnostics (IVDs) with regard to regulatory compliance. We guide you at all levels and at every stage of the product lifecycle to meet the requirements of the IvDO (In Vitro Diagnostics Ordinance) or the IVDR (Regulation (EU) 2017/746) and other country-specific regulations.Our expert team is ready to help you, whether developing new in vitro diagnostics (IVDs), maintaining existing IVDs, entering new target markets, post-market surveillance (PMS), performance evaluation, clinical performance studies, post-market performance follow-up (PMPF), or developing and optimizing your quality management processes.Through an efficient interaction of the various quality management processes, we collectively create the development and maintenance of safe and reliable products throughout the entire product lifecycle.With Metecon, you have a strategic partner at your side who listens to you, thinks along with you, and creates individual solutions. We understand your specific challenges and work closely with you to find the optimal path to market and post-market surveillance for your product.You can trust us. Together, we will ensure that your in vitro diagnostics (IVDs) meet regulatory requirements and that you can operate successfully in the marketplace.
ClinO-MD replaces ClinO
As of 26 May 2022, clinical trials involving in vitro diagnostics (IVDs) will no longer be regulated by the Clinical Trials Regulation (ClinO), but by ClinO-MD. This allows for more comprehensive regulation of human research with all medical devices, including in vitro diagnostics (IVDs), and tightens the requirements for safety and performance demonstrations in line with European regulations.Do you have any questions about the requirements for safety and performance records? Our IVD-Expert Dunja Schildge-Reichmann will be happy to help you.
Our service for the regulatory compliance of your in vitro diagnostics (IVDs)
Strategic partnership: As your strategic partner, we support you in successfully launching and maintaining your IVD products on the market in accordance with the applicable standards and regulations, both within and outside the EU.Professional document review and preparation: Our experienced team reviews and optimizes your existing registration documents of your IVD(s) according to the requirements of the IvDO, the IVDR, and other relevant regulations and standards. In addition, we support you in the preparation of customized documents to ensure that you meet all regulatory requirements.Quality management at the most advanced level: Together with you, we develop a robust quality management system (QMS) specifically for in vitro diagnostics (IVDs). Our goal is to implement a QMS in accordance with the requirements of IvDO/IVDR, ISO 13485, and other relevant standards to ensure the quality, safety, and efficacy of your IVDs.Partnership with test laboratories and Notified Bodies: We support you in finding and communicating and coordinating with test laboratories, CROs and Notified Bodies (Swissmedic and EU) for the certification and evaluation of your IVDs. This ensures a trouble-free process for you.Knowledge transfer and training: Through our customized training and education, we enable effective knowledge transfer within your team. We offer cross-departmental workshops and training on your specific regulatory topics to enhance collaboration between teams.Competent Representative Services: As EU Authorized Representative (EU-REP), Swiss Authorized Representative (CH-REP) and PRRC (Person Responsible for Regulatory Compliance) for your in vitro diagnostics (IVDs), we take over all associated regulatory obligations and ensure smooth communication with the relevant authorities.Temporary manufacturer responsibility: If required, our sister company CEyoo GmbH can handle temporary manufacturer responsibility for your in vitro diagnostics (IVDs); there can be many reasons for this - contact us!Innovative solutions for the digital future: We are here to assist you in selecting digital solutions for your regulatory requirements in the field of In Vitro Diagnostics (IVD). We support you in analyzing your specific needs and choosing suitable software to efficiently and successfully handle your compliance tasks.Contact us today to discover more about our comprehensive regulatory compliance services for IVD manufacturers. Together, we'll ensure that your in vitro diagnostics (IVDs) meet regulatory standards and that you can operate successfully in the marketplace.Connect now and optimize regulatory compliance for your in vitro diagnostics (IVDs)!
We are looking forward to hearing from you
Our Services in detail
- Review and update Technical Documentation for existing in vitro diagnostics (legacy devices) according to Swiss (IvDO 812.219) and EU (IVDR 2017/746) regulatory requirements,
- Preparation of standard and regulatory compliant Technical Documentation (Switzerland, EU, and international) for existing products as well as in the scope of new developments,
- Communication with Swissmedic, Notified Bodies, authorities and testing laboratories for analytical and/or clinical studies,
- Review and adaptation of the implementation of IvDO and IVDR requirements based on the latest MDCG guidelines,
- Support in the Clinical Affairs area, preparation of literature-based performance evaluations, and creation of applications to ethics committees and competent authorities for approval procedures of clinical studies,
- Revising and adapting quality management systems (ISO 13485, ISO 9001, ISO 15189): Analysis of change requirements, adaptation of processes, and support during audits.
- Compliance with the software development process according to IEC 62304,
- Performance evaluation for software products,
- Support in the preparation of GSPR (General Safety and Performance Requirements) and establishment of quality management systems (QMS) for in-house in vitro diagnostics,
- Partnerships with laboratories: We cooperate with various laboratories and are happy to assist you in finding suitable laboratories or providers of human samples such as serum or plasma,
- Planning, execution, and documentation of PMS/PMPF activities.
We are there to assist you with any of these services to ensure that you meet regulatory requirements and can successfully bring your in vitro diagnostics (IVDs) to market. Contact us!