Tailored regulatory expertise on complex CE marking and MedDO/IvDO topics.
The EU Regulations on medical devices (EU MDR) and on in-vitro diagnostic devices (IVDR) as well as the Swiss Ordinances on medical devices (MedDO) and on in-vitro diagnostic devices (IvDO) have introduced numerous new requirements where even experienced manufacturers need support to understand.
To gain clarity on these new requirements, we offer you tailored expert opinions, specific input with rapid feedback that saves you time in your project and ensures that you are heading in the right direction.
We conduct regulatory reviews of the qualification and/or classification of your product portfolio under the EU MDR/IVDR, with clear explanation of the implications.
We provide regulatory recommendations on “borderline” products, Procedure Packs or Systems, and configurable devices.
We give guidance and templates to bring your Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) or Post-Market Performance Follow-up (PMPF) activities into compliance with the EU MDR/IVDR. Including setting thresholds and indicators that are meaningful for your device and appropriate to its risks.
We deliver regulatory recommendations on your Clinical Development Plan and Clinical Evaluation Plan under the EU MDR, particularly for “legacy” Class I devices.
We conduct detailed gap analysis of your “private label” approach for compliance with EU MDR/IVDR.
We customize our regulatory support for your role as a Swiss importer or distributor according to the requirements of the new MedDO/IvDO.
Our support can be structured in a modular manner to suit your needs at your own pace. In our offer, an experienced Regulatory Affairs professional reviews the current status of your regulatory assumptions and specific questions to identify any misconceptions, explain applicable requirements and implications, clarify further questions and check what to consider for appropriate compliance.
The EU MDR has expanded the definition of medical device, integrated products without medical purpose (e.g. liposuction equipment), and revisited classification rules (particularly for software, substance devices, nanomaterial devices, and closed loop devices), resulting in far more stringent requirements. In addition, the EU MDR has brought clarity to Procedure Packs and Systems, a topic often misinterpreted by manufacturers and Notified Bodies, and introduced the concept of “configurable device”. It is therefore important to reassess the manufacturer’s product portfolio to clearly differentiate where each item fits.
The changes brought by the IVDR are even bigger as in-vitro diagnostic device (IVD) classification has moved from a list-based approach, where most IVDs were subject to self-declared CE-marking without Notified Bodies, to a rule-based approach that has left few IVDs to be self-declared. And despite the extended transitional periods granted to “legacy” IVDs, the efforts to upgrade the manufacturer’s QMS and the product’s evidence of compliance require early actions.
Be mindful of common compliance misconceptions.
Other regulatory aspects frequently misinterpreted, despite the guidance documents issued by MDCG, are the implications for “private labelling” (or “Own Brand Labellers”, OBL), PMS activities vs. PMCF activities, the type and extent of clinical data needed for CE marking, the implementation of labelling requirements for medical device software, or the QMS requirements.
And the Mutual Recognition Agreement between EU and Switzerland ceased to apply to medical devices and IVDs, turning Switzerland into a “third country” with new legislation (particularly, MedDO and IvDO) that introduces Swiss-specific requirements in addition to CE-marking. Amongst them, the need to appoint a Swiss Authorised Representative. Decomplix has extensive experience in this role and can help foreign manufacturers navigate the still evolving requirements.
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Regulatory Affairs Director
Helena Lacalle is a Regulatory Affairs professional with over 20 years of experience in strictly regulated fields like medical devices and pharmaceuticals. Helena Lacalle holds a pharmacist degree from the University of Barcelona, a Master degree in Statistics from the University of Neuchatel, Switzerland, and has strong language skills in English, French, and Spanish. With her extensive regulatory expertise, she supports Decomplix’ customers both on strategic levels and on detailed regulatory questions.