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MEDICAL DEVICE

3B Biotech helps medical device companies develop their clinical strategy. We provide solutions for clinical evidence collection and support to obtain and maintain CE mark

A dedicated medical device team advise our Clients with a strategic and practical approach to perform Clinical Investigations, during the entire life-cycle of a medical device

NEW EUROPEAN REGULATION

The EU has released new guidance governing medical devices: our support to manage your MDR transition plan

With effect from 26 May 2021, the new Medical Device Regulation (MDR – Regulation EU 2017/46 replaces Directive 78/79/EC, after a transition period.

For any device already on the market – “legacy devices”- manufacturers will have to establish evidence of the compliance with the new regulation latest by May 2024.

3B Biotech Research helps medical device manufacturers to design the best strategy to the conformity assessment during this complex transition period.

Our most recent experience include the following areas:

  • Cardiology
  • Neurology
  • Cardiovascular
  • Gastroenterology
  • Respiratory (with a specific focus on medical gas devices) 

CLINICAL SUPPORT FOR MEDICAL DEVICES

Pre Market Clinical Studies

CLINICAL INVESTIGATIONS

The objective of a clinical investigations is to demonstrate the conformity with claims of the medical device within the scope of the intended use. We are able to fully manage 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  
  • EC and CA submissions 
  • Monitoring 
  • Study and Site Files 
  • Data Management
  • Biostatistics

A CLINICAL EVALUATION is required for all medical devices. It is based on data generated from clinical investigations and/or literature reports related to device in question or a comparable device. Clinical data should be obtained prior the CE-marking and continuously updated. We support our Clients in the assessment of available clinical data and in the generations of new ones by defining an effective clinical development strategy.

Post Market Clinical Follow-up Studies

PMCF studies are designed to identify the potential for residual risks of a CE Marked device, to collect data and gain evidence regarding the long-term clinical performance of the product.

The EU – MDR 2017/745 places greater emphasis on PMCF and introduces changes to the procedure for demonstrating PMCF compliance. In fact, data accepted under the previous European Medical Devices Directive (MDD) may no longer be sufficient under the new MDR.

We help our Clients to:

  • Evaluate the need of a PMCF Study;
  • Dealing and negotiate with your notified body;
  • Define the study protocol;
  • Conduct the PMCF Study.

Regulatory affairs support for medical device

  • CE marking process and Renewal of CE MARK according to new MDR 745/2017
  • Re-classification according to RULE 21 of MDR 745/2017
  • Creation / update of the dossier (Global Technical File) according to the rules and the sections reported in the new regulation / MDCG;
  • Evaluation of packaging materials and artworks for compliance
  • Registration and Management of the EUDAMED DATABASE
  • Elaboration of Clinical Evaluation Report (CER) in cooperation with a team of regulatory, safety and medical experts.
  • Preparation of the State of Art (SOA)
  • Preparation of PMCF plan and Report

CE marking process and Renewal of CE MARK according to new MDR 745/2017

In order to commercialize medical devices, a CE Mark certificate is needed. This certification verifies that a device meets all regulatory requirements for medical devices under the new Medical Devices Regulation (MDR 2017/745). 3B Biotech can support you in all the steps needed for the obtainment of a new CE mark of in case, you have a Legacy Device that need to be recertified. This also performing a  GAP Analysis versus the new REG UE 2017/745 in order to update the technical files of the device and obtain the renewal of CE MARK. 

Re-classification according to RULE 21 of MDR 745/2017

The new classification Rule 21 refers to the medical devices composed of substances or combinations of substances and that are intended to be introduced into the human body through a body orifice or applied to the skin and that are absorbed by or locally dispersed into the human body.

Creation / update of the dossier (Global Technical File) according to the rules and the sections reported in the new regulation / MDCG and evaluation of packaging materials and artworks for compliance

The medical device technical file is a must-have document for devices to be sold

The file contains detailed information about your medical device, its design, intended use claims, composition, and clinical evaluations. It’s essentially an “everything you must know” document for a device.

Registration and Management of the EUDAMED DATABASE

The creation of a European database on medical devices (EUDAMED) is one of the key aspects of the new rules on medical devices  

EUDAMED will provide a living picture of the lifecycle of medical devices that are made available in the European Union (EU). It will integrate different electronic systems to collate and process information about medical devices and related companies. In doing so, EUDAMED aims to enhance overall transparency, including through better access to information for the public and healthcare professionals, and to enhance coordination between the different Member States in the EU. 

Elaboration of Clinical Evaluation Report (CER) in cooperation with a team of regulatory, safety and medical experts.

this document is prepared taking into consideration what is reported in the regulation and in the relative MDCG. A team of Experts works on the preparation of the CER: regulatory, safety and medical experts.

Preparation of the State of Art (SOA)

Developed stage of current technical capability and/or accepted clinical practice in regard to products, processes, and patient management, based on the relevant consolidated findings of science, technology, and experience.

Vigilance and surveillance support for medical device

We provide a full range of services for both device clinical studies and post-registration needs.
Based on Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), manufacturers have the obligation of reporting any serious incident involving one (or more) of their medical devices as well as any safety corrective action taken to the relevant competent authorities.

3B BIOTECH will support its clients in the management of the incident reports to the Competent Authorities and advice during the investigation and preparation of corrective actions.

3B BIOTECH can support also in the preparation of:

PMS plan and report: a MDR Vigilance plan must be set out as a component of the PMS plan required by Article 83.

The Vigilance plan must include methods for collecting data on serious incidents, distinguishing serious incidents from expected side effects, analysing serious incidents and procedures for escalating to competent authorities, receiving and analysing complaints and compiling data on trends

PMCF plan and report: PMCF concerns the proactive collection and analysis of clinical data through the generation of Real-World Evidence (RWE) on the safety and performance of the device in normal use.

PSUR: For each device and where relevant for each category of group of devices;

The PSUR summaries data gathered as a result of the PMSP.

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