Medical Devices
GB Pharma supports medical device companies in developing and executing the best clinical strategy and regulatory compliance. We provide solutions for clinical data collection and obtaining and maintaining CE marking
Our dedicated team is responsible for defining the strategic approach and conducting the necessary clinical studies throughout the medical device life cycle.
THE TRANSITION TO MDR
NEW EUROPEAN REGULATION
Implementation of the new Medical Device Regulation (MDR) is an ever-evolving process. GB Pharma guides you in interpreting and defining the best strategy.
Effective May 26, 2021, the EU released new guidelines governing medical devices, the new Medical Device Regulation (MDR – REG 2017/46) that replaced Directive 78/79/EC, after a transition period. Most recently, REG 2023/607 amends the transitional provisions for certain medical devices, granting a longer transition period for “legacy Devices,” until December 31, 2027 or December 31, 2028 depending on the risk class.
GB Pharma, with regulatory expertises combined with clinical experience, ensures the Client’s timely adjustment to the new MDR, guiding them through this complex transition period.
Our most recent experience includes the following therapeutic areas:
- Cardiology
- Neurology
- Cardiovascular
- Gastroenterology
- Respiratory (including a focus on medical gas devices)
CLINICAL INVESTIGATIONS
PRE-MARKET CLINICAL STUDIES
The objective of a clinical investigation is to demonstrate device compliance with safety and efficacy (performance) requirements under conditions of normal device use.
We can handle all types of clinical investigations with medical devices from Class I to Class III, as well as implantable devices.
Below is a list of our services for Clinical Investigations:
Project Management
Ethical and regulatory submissions
Monitoring
Management of Study Files
Data Management
Biostatistica
Clinical evaluation
A CLINICAL ASSESSMENT is required for all medical devices. It is based on data generated from clinical investigations and/or dossiers related to the device in question or a comparable device. Clinical data are required for CE marking purposes and updated continuously.
At GB Pharma a we support our Clients in evaluating available clinical data and generating new data by defining an effective clinical development strategy.
POST-MARKET CLINICAL STUDIES
Postmarketing clinical follow-up studies – PMCF
Post Market Follow Up studies are aimed at identifying potential residual risks of a CE-marked device and collecting clinical data to support the long-term clinical performance of the product.
EU – MDR 2017/745 emphasizes the use of PMCFs and introduces some changes in compliance procedures and rules. Concretely, data considered sufficient under the previous EU MDD may no longer be sufficient under the new regulation.
GB Pharma deals with:
Verify the actual need for a Post Market clinical study.
Manage the relationship with the Notified Body.
Define the study design and protocol
Conducting the study
MARKETING SURVEYS
GB Pharma offers comprehensive support in the execution of "Marketing Surveys" aimed at different objectives
We manage market surveys aimed at collecting data on device usage and performance, and any other information deemed useful by the manufacturer.
These surveys can be conducted through the distribution of electronic questionnaires, administered through a dedicated platform aimed at collecting aggregate data. The electronic platform resides on a website specifically created for the survey itself.
Surveys can be in different stages, with differentiated questionnaires, and can target physicians, nursing staff, patients, or other categories of interest in achieving the survey purpose.
GB Pharma takes care of all activities involved in the market survey, including:
Preparation of the questionnaire and its distribution
Implementation of the ad-hoc platform
Stipulation of contracts
Data Collection
Descriptive statistical analysis
REGULATORY AFFAIRS
Regulatory Affairs for Medical Devices
- CE marking process and CE marking renewal according to MDR 748/2017
- Re-classification according to RULE 21 of MDR 745/2017
- Creation and updating of the Dossier (Global Technical File) according to the rules and sections given in the new Regulation/MDCG
- Evaluation of the suitability of packaging materials and “artworks”
- User registration and management of the EUDAMED DATABASE.
- Preparation of the Clinical Evaluation Report (CER) in collaboration with the regulatory team, safety experts and physicians.
- Preparation of the State of the Art (SOA)
- Preparation of PMCF plan and report
Re-classification according to RULE 21 of MDR 745/2017
Classification according to Rule 21 refers to medical devices composed of substances or combination of substances that are designed to be introduced into the human body through an orifice or applied to the skin, then absorbed or dispersed within the body.
Creation or updating of the dossier (Global Technical File) according to the rules and sections reported in the Regulation/MDCG and assessment of compliance of packaging materials and “artworks”
The medical device technical file is a key document for the device to be sold. The file contains all necessary and detailed information regarding the design, indications for use, composition and clinical evaluation of the device.
Registration and management of the EUDAMED DATABASE.
The creation of a European Database of Medical Devices (EUDAMED) is one of the central aspects within the new rules.
EUDAMED will provide an up-to-date status of the lifecycle status of medical devices distributed in the European Union (EU) EUDAMED will integrate different electronic systems to collect and process information on medical devices and related companies.
The aim is to promote total transparency and allow easy access to information for both the public and professionals, while also supporting coordination between different EU member states.
Preparation of Clinical Evaluation Report (CER) by our team of experts in regulatory affairs, safety and medical.
This report is prepared on the basis of the regulations stated in the regulation and the relevant MDCG.
State of the Art Preparation (SOA).
It is the highly articulated document that defines the current state of technical development and/or accepted clinical practice regarding devices, processes and patient management, based on relevant and established findings of science, technology and experience.
VIGILANCE AND SURVEILLANCE
Vigilance and Surveillance of Medical Devices
We offer the full range of services to support clinical trials and post-registration needs.
According to EU Regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR), manufacturers have an obligation to report to the relevant authorities any serious incidents involving their medical devices as well as any corrective safety action taken.
GB Pharma handles related reports to the Competent Authority and advises in the process of preparing corrective actions.
GB Pharma also supports Clients in the preparation of:
- Post Market Safety (PMS) plan and report:
the vigilance program must be shared within a post-market safety plan under Article 83 MDR.
This Vigilance plan must state methods for collecting data of serious incidents, differentiating these from expected side effects, analyzing serious incidents, and providing procedures for receiving and recording reports and escalating to the appropriate authorities.
- Post Market Clinical Follow Up (PMCF) plan and report:
the PMCF covers the spontaneous collection and analysis of clinical data through the generation of Real-World Evidence (RWE) on the safety and performance of the device used in accordance with the intended use.
- PSUR: mandatory for each medical device and if necessary for each device category. The PSUR summarizes the data collected as a result of the PMSP.