Medical Devices and In-Vitro Diagnostics

Regulatory Context

A medical device is any ‘article’ intended to be used specifically for diagnostic and/or therapeutic purposes for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease (e.g. urinary catheter), control of conception (e.g. condom), diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap (e.g. bone cement) or investigation, replacement or medication of the anatomy or of a physiological process (e.g. hip replacement).

A medical device does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but may be assisted in its function by such means.

A medical device may not be placed on the market of a Member State unless it is appropriately CE marked which indicates its conformity with the provisions of the medical device regulations.

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Current issues in this Sector

Managing regulatory compliance
All stages of the product life-cycle, from research and development through manufacturing and marketing of products, are governed by multiple regulations both at national and European level and the number of regulations are continuously increasing. Non-compliance can cost a company their reputation and a lot of money due to fines, complaints, recalls, additional audits and more. In the wake of the recent and widely reported defective silicone gel breast implants and hip replacement products new, more stringent, regulations have already been proposed by the European Commission in order to ensure an adequate legal framework to guarantee the safety of medical technology, especially for high-risk devices.

Supply chain control mechanism and identification/traceability (Unique Device Identification (UDI))
Monitoring and keeping track of devices placed on the European Union’s (EU’s)  ‘borderless’ market is always a challenge. The mandatory information to be input into databases (i.e. EUDAMED) by Notified Bodies, Manufacturers, Authorised Representatives, Importers, Distributors and Member States is increasing. EUDAMED, the central registration database, will reduce the administrative burden on manufacturers by removing diverging national registration requirements and thus reducing compliance costs. A UDI system is an additional labelling requirement for medical devices to provide early detection of defective devices and facilitate device recalls, thereby enhancing patient safety and reducing medical errors. This system will become mandatory as part of the new Medical Device and In Vitro Diagnostic (IVD) Regulations.

Notified Body intervention
Medical devices are not subject to any pre-market authorisation by a regulatory authority but to a conformity assessment which, for medium and high risk devices, involves an independent third party, known as a ‘notified body’. Oversight and control of notified bodies is vital to ensure a high level of patient safety and confidence in the regulatory system, especially in the assessment of the manufacturers’ clinical evaluation. Under the new proposed Medical Device Regulations a new scrutiny system is introduced, to review the notified body’s preliminary assessments of manufacturer files for high-risk, innovative devices. At the same time notified body oversight of manufacturers will be significantly strengthened including unannounced factory inspections and sample testing.

Difficulties to be avoided

Regulatory Strategy and Classification
The medical device market changes frequently in terms of technology, risk potential, marketing and reimbursement. Lack of adequate planning and regulatory strategy (regulatory roadmap) for a chosen market(s) can cause higher development costs and unexpected delays resulting in a longer development cycle. In view of the diverse nature of the devices and technological progress in this field, the borderline classification between, for example, medicinal products and medical devices is sometimes difficult to draw due to hybrid technologies. It is therefore paramount to ensure that the product to be developed is correctly classified within each jurisdiction and therefore the route to market strategy appropriate. The classification system of in vitro diagnostics will be significantly changed by the new IVD regulations.

Clinical Evaluation
Since the amendments to directive 93/42/EEC in March 2010 (via directive 2007/47/EC) all medical devices, regardless of risk or classification, must include a clinical evaluation (analysis of clinical data from clinical investigation, clinical experience and/or clinical literature review) in accordance with Annex X to demonstrate conformity with the essential requirements. Clinical data must be sufficient and of an appropriate quality & quantity to demonstrate safety, performance, risk benefit analysis and support of labelling claims for the device in question. Clinical literature and data from equivalent devices is critical to include in an evaluation, even if a clinical investigation is performed. The clinical evaluation is a standalone document and must be actively updated (future device changes, amendments, post-market clinical follow-up, vigilance, etc.).

Combination devices
Where a device incorporates, as an integral part, a medicinal product which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC. Regulatory and clinical strategy should incorporate additional activities, resources and timelines for the drug component including drug agency interaction (scientific advice) and review times. 

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