What are the experienced CRO solutions available for Medical Device EMA Compliance? European Medicines Agency is the organ responsible for
A Clinical Evaluation Report (CER) is a document that exposes a clinical assessment’s conclusions of a medical device. The report
ECLEVAR MEDTECH, a Paris-based global CRO, has announced that it will provide clinical trial services using the Oracle Clinical One
The heart is a vital organ responsible for pumping blood throughout the body, ensuring oxygen and nutrients are delivered to
Join us for an insightful webinar that will equip you with the knowledge and skills necessary to navigate the complexities
The Japanese market for medical devices is expanding rapidly, presenting significant opportunities for pharmaceutical and medical device companies. Japan’s aging
Regulatory Authority in Japan The authorization of medical devices in Japan represents a challenge for European manufacturers. But it’s not
In the European Union, medical devices are divided into four categories based on their intended use and level of risk.
Selecting the right Contract Research Organization (CRO) in the development and commercialization of medical device When it comes to choosing
The European regulatory landscape has significantly changed over the past 10 years, particularly concerning requirements for Clinical Evaluation (CEP/CER). This
Summary Eclevar MedTech can assist manufacturers to comply with post-market surveillance requirements for medical devices. The manufacturer should establish and
Eclevar Australia provides an update on Australian regulatory pathway for breakthrough innovative medical devices – March 2023 The TGA priority
Learn more about Software and Artificial Intelligence as a Medical device in UK Software and Artificial Intelligence as a medical device
Eclevar Australia provides an update on Australian regulatory requirements for personalized including 3D printed medical devices – February 2023 TGA
Creating the Future in Clinical Research with CROs Using Real-World Data Tuesday, February 14, 2023, 9 am CT, 10 am
A shift to an international approach to safety and performance? Regulators across the globe know, only to well, the challenges
Eclevar Australia provides an update on TGA acceptance of overseas approvals for ARTG inclusion of medical devices – December 2022
PMCF is considered under the regulations to be a continuous process that has two critical functions – Firstly it is
If you wish to place a medical device on the US market, and a Premarket Approval Application(PMA) is not required,
Eclevar Australia provides an update on Australian regulatory requirements for software-based medical devices – January 2023 TGA is aligning its
We are proud that ECLEVAR will work closely with the British government on the future study of EU regulation in
Introduction The principle of ISO 14155:2020 Annex I post-market stage applies to clinical investigations as per MDR 2017/745 Article 74.1
MedTech Digital Week PMCF Clinical Investigations and Other Studies 04 Oct 2022 – Question and Answers Introduction On 04. October
Are the Australian regulations for medical devices aligned with the new EU Medical Devices Regulation and In Vitro Diagnostic Medical
Introduction While under the MDD 93/42/EEC and AIMDD 90/385/EEC and Medizinproduktegesetz (Medical Device Act, MPG) the submissions for pre-CE mark
Conducting a Clinical investigation (CI) in the UK If you are planning on conducting a clinical investigation with a Medical
Introduction For post-market follow-up clinical investigations (PMCF CI) as per Art 74(1) MDR 2017/745, submissions to the Ethics Committee (EC)
PMCF – What’s the use of a survey? Post Market Clinical Follow-up (PMCF) is the subject of much debate. PMCF
MDCG Guidance documents summary series: Introduction Under MDD and AIMDD already it was required to provide patients with an
When a medical device is placed on the market, it is subject to Post-Market Surveillance (PMS) according to MDR 2017/745.
Post-market Clinical Investigation with Medical Devices in Europe as per ISO 14155:2020 and MDR 2017/745 Introduction This blog summarizes the
A reflection on our session at LSI Europe in September and key messages around classification of medical devices.
Pre-market Clinical Investigation with Medical Devices in Europe as per ISO 14155:2020 Introduction Last week, ECLEVAR posted a blog
Eclevar Australia response to TGA Consultation on proposed regulatory changes for clinical trials of medical device – 17 August 2022
We have looked at the UK and the EU, where we saw many synergies in how they use equivalence. This
MDCG Guidance documents summary series: MDCG 2022-5 – Guidance on borderline between medical devices and medicinal products under Regulation (EU)
UKCA Mark: PMS & PMCF – what changes are proposed for the UK? In looking to achieve more harmonization across
ABHI & CPI : The Health Technology Regulatory and Innovation Programme Eclevar UK were pleased to be asked to support
MDCG Guidance documents summary series: MDCG 2029-9 Rev.1 – SSCP Summary of safety and clinical performance A guide for manufacturers
Clinical decision support software (CDSS) – how it is regulated in Australia TGA publishes new guidance on exemption criteria for
Clinical evaluations rout: equivalence under EU MDR Following on from our blog on equivalence in the UK, we will now
MDCG Guidance documents summary series: MDCG 2020-10/1 – Safety reporting in clinical investigation of medical devices under the Regulation (EU)
UKCA Mark & Alternative routes to market – a risk or an important step towards global regulation? Next under the
MDCG 2021-28 – Substantial modification of clinical investigation under Medical Device Regulation Introduction As per MDR 2017/745 Art. 75 Substantial
Equivalence in UK – Great Britain – How to use it! Different regulatory jurisdictions utilise ‘equivalence’ in different ways, from
MDCG 2021-8 – Clinical investigation application/notification documents Introduction EUDAMED (electronic system referred to in Article 73 of the MDR)
Vigilance reporting Requirements for Manufacturers and Authorized Representatives in Germany Introduction With the implementation of the EU MDR 2017/745 into
UKCA Health inequalities – can the regulations do more? Health inequalities is one of the five pillars the MHRA are
Introduction Already under the MDD and AIMDD, clinical investigations with non-CE-marked devices (now Art. 62 MDR) and with CE-marked devices
PRRC – An overview of the role and requirements of the person responsible for regulatory compliance under Article 15 of EU MDR and EU IVDR.
Duration: 30 min Location: Dublin Language: English The EU MDR defines Post-Market Clinical Follow-up (PMCF) as a continuous process that updates the
Duration: 30 min Location: Dublin Language: English Accessing the European and UK markets bring challenges that can lead to delays in your
Introduction Reporting of Serious adverse events is always a very critical part of a Clinical Investigation. With the implementation of
Eclevar UK are pleased to announce their first webinar in a series around the UKCA mark and the future regulations.
EU IVDR update, Judith Prevoo, Regulatory Lead – Regulatory Services, BSI A very informational and interesting, BSI/AAMI International Standards &
It is fair to say that the MedTech sector breathed a sigh of relief when MHRA published the consultation
Study Initiation Visit in clinical Investigations – what to cover: ISO 14155:2020, Data Protection, and SAE reporting requirements To meet
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