MDR Analysis: Does your medical device fall under the scope of new European regulations?

By Stewart Eisenhart and Ronald Boumans, Emergo Group The draft MDR text (see page 32 for the definition) as well as its accompanying Annex XV (page 352) lay out clear indications as to which types of devices will have to comply with the new requirements and which will be covered by separate regulations. Before we go into detail, you might want to read last week’s high level overview of the MDR changes, or download our whitepaper on the MDR. It is important to note that the MDR covers devices that previously fell under two separate European directives, the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD); in vitro diagnostic devices will be covered by the new In Vitro Diagnostics Directive (IVDR). How the MDR defines “medical device” The MDR defines the term “medical device” as any “instrument, apparatus, appliance, software, implant, reagent, material or other article” intended to be used for any of the following medical purposes: Diagnosis, prevention, monitoring, treatment or alleviation of disease, disability or injury, where prevention of disability and injury is excluded Investigation, replacement or modification of an anatomical, physiological or pathological process Providing data via in vitro examination of samples derived from a human body The new regulation also specifies particular types of products that also qualify as medical devices requiring CE Marking: Products inte...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Blog Emergo Group Source Type: news

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This study describes the epidemiology of STH and S. stercoralis infections in twelve remote villages surrounding Ranomafana National Park (RNP), Ifanadiana, Madagascar. Questionnaires and stool samples were collected from 574 subjects from random households. The Kato-Katz method and spontaneous sedimentation technique were used to examine stool samples for evidence of infection. Infection prevalence rates were 71.4% for Ascaris lumbricoides (95% CI: 67.7-75.1), 74.7% for Trichuris trichiura (95% CI: 71.1-78.2), 33.1% for hookworm (95% CI: 29.2-36.9), and 3.3% for Strongyloides stercoralis (95% CI: 1.84-4.77). Participants ...
Source: Pathogens and Global Health - Category: International Medicine & Public Health Tags: Pathog Glob Health Source Type: research
CONCLUSION: The experience of specific SHCs in the first 6 months after an SCI is related to greater long-term disability. In order to reduce the disability burden of people with SCI, efforts should be directed toward early prevention of these SHCs. PMID: 30882288 [PubMed - as supplied by publisher]
Source: Journal of Spinal Cord Medicine - Category: Orthopaedics Tags: J Spinal Cord Med Source Type: research
CONCLUSION: The role of end-users in the process of translation and cross-cultural adaptation was crucial. This collaborative process resulted in a Dutch version of the PEDI-CAT that has been optimally adapted to the Dutch language and culture. PMID: 30883373 [PubMed - as supplied by publisher]
Source: Journal of Pediatric Rehabilitation Medicine - Category: Rehabilitation Tags: J Pediatr Rehabil Med Source Type: research
Authors: Manafnezhad J, Salahzadeh Z, Salami M, Ghader F, Ghojazadeh M Abstract BACKGROUND: Chronic neck pain is associated with various myofascial trigger points (MTrPs). OBJECTIVE: A single-blind randomized clinical trial was designed to compare the effects of extracorporeal shock wave therapy (ESWT) with dry needling (DN) techniques on the upper trapezius muscle trigger point in patients with non-specific neck pain (NSNP). METHODS: Seventy patients with NSNP and active MTrPs of the upper trapezius muscle were randomly divided into two groups: an ESWT group (n= 35) and a DN group (n= 35). Treatment sessio...
Source: Journal of Back and Musculoskeletal Rehabilitation - Category: Orthopaedics Tags: J Back Musculoskelet Rehabil Source Type: research
Authors: Lee HI, Lee KW, Park D, Park MJ Abstract The aim is to report the long-term clinical results after pisiform excision in patients with refractory flexor carpi ulnaris (FCU) tendinopathy. We performed pisiform excision in 14 patients with recalcitrant FCU tendinopathy, who had failed conservative treatment. Nine patients were followed-up for more than 2 years. Pre-operative pain visual analog scale (VAS) was extracted from the electronic medical records. Post-operative symptoms and function were assessed with pain VAS, quick disabilities of arm, shoulder and hand (DASH) score, patient rated wrist evaluation ...
Source: Acta Orthopaedica Belgica - Category: Orthopaedics Tags: Acta Orthop Belg Source Type: research
Pinnacle® modular metal-on-metal articulation in primary total hip arthroplasty: mid-term results of 195 cases. Acta Orthop Belg. 2018 Dec;84(4):407-414 Authors: Colen S, Kuiper JW, Thys P, De Schuyffeleer S, Mulier M Abstract Studies concerning Pinnacle® modular metal-on- metal (MoM) total hip arthroplasty (THA) show better results than for most other MoM THAs. The goal of this study was to report on the revision rate, clinical outcome and metal ion levels regarding this specific prosthesis. Retrospectively selected patients were evaluated clinically, and Visual Analogue Score for pain (VAS), ...
Source: Acta Orthopaedica Belgica - Category: Orthopaedics Tags: Acta Orthop Belg Source Type: research
CONCLUSION: Our findings suggest that LiCl protects neural cells and effectively enhances locomotor function, which was done through up-regulation of endogenous BDNF expression in rats with SCI. ABBREVIATIONS: SCI: spinal cord injury; LiCl: lithium chloride; BDNF: Brain-derived neurotrophic factor; NT3: Neurotrophin-3; BBB: Basso, Beattie, Bresnahan; TrkB: Tropomyosin receptor kinase B; TUNEL: Terminal deoxynucleotidyl transferase dUTP nick end labeling. PMID: 30879425 [PubMed - as supplied by publisher]
Source: Neurological Research - Category: Neurology Tags: Neurol Res Source Type: research
This study investigates whether sarcopenia affects fusion rates and outcomes following single-level lumbar decompression and fusion. A retrospective analysis was undertaken of 97 consecutive patients who underwent a single level lumbar fusion for degenerative spondylolisthesis. Demographics, perioperative data, and patient reported clinical outcomes were collected. Measurements of paraspinal muscle CSA were made using a standardized protocol at the level of the L3-4 disc space on a preoperative lumbar MRI. Univariate analysis was used to compare cohorts with regards to demographics, comorbidities, and clinical outcomes. Of...
Source: Journal of Clinical Neuroscience - Category: Neuroscience Source Type: research
Conclusions: In Kenya, more needs to be done to change the attitude towards disability from the medical and moral (religious/cultural) models to an approach leaning towards the social model, so that developmental disabilities are not viewed negatively.
Source: International Journal of Environmental Research and Public Health - Category: Environmental Health Authors: Tags: Article Source Type: research
CONCLUSION: Patient satisfaction with maxillary IODs on two implants did not change from baseline to 4 years and was high at 4 years of function. PMID: 30883624 [PubMed - in process]
Source: International Journal of Oral and Maxillofacial Implants - Category: ENT & OMF Tags: Int J Oral Maxillofac Implants Source Type: research
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