US FDA Publishes Proposed Rule on Non-US Clinical Studies
If the proposed rule on US FDA requirements for accepting data from medical device clinical studies conducted outside the United States becomes final, manufacturers will face significant new requirements.
New US Regulation on CGMPs for Combination Products
US FDA has recently published its long-awaited regulation on current good manufacturing practices (CGMPs) applicable to combination products. The regulation becomes effective on 22 July 2013 and applies to combination products already on the market in addition to newly developed products.
Make Your Voice Heard via UK Public Consultation on New Medical Device Legislation
The UK Medicines and Healthcare products Regulatory Agency has launched a public consultation that presents its views and requests opinions from stakeholders on the newly proposed medical device legislation. This article discusses the consultation and suggests that readers consider responding.
Proposed New European Medical Device Regulations
After more than 20 years of broadly accepted success, the European directives on medical devices are in line for a major overhaul. The European Commission has recently published its proposals for regulations on medical devices and in vitro diagnostic medical devices. This article highlights se...
Proposed Guidance on IVD Clinical Evidence and Performance Evaluation
Manufacturers of IVD devices should be aware of three proposed Global Harmonization Task Force guidance documents on clinical evidence for IVD devices. The documents cover definitions and terminology, determining scientific validity, performance evaluation and clinical performance studies.
Preparing for a US FDA Medical Device Inspection, Part 2
US FDA is increasing quality system inspections of foreign medical device manufacturers. Part 1 of this article discussed why this is occurring, situations that European manufacturers should avoid, the importance of US FDA inspection preparation, and two topics that should be covered in inspecti...
Preparing for a US FDA Medical Device Inspection, Part 1
US FDA is increasing quality system inspections of foreign medical device manufacturers. Part 1 of this article discusses why this is occurring, situations that European manufacturers should avoid, the importance of US FDA inspection preparation and two topics that should be covered in inspectio...
Early Feasibility Medical Device Clinical Studies
US FDA recently issued important draft guidance that describes new approval policies for early feasibility medical device clinical studies of significant risk devices. This article discusses the draft guidance and pilot programme that US FDA has initiated for testing the new policies.
Guidance to Notified Bodies on Checking Clinical Evaluations
There are two European documents that contain guidance for assisting Notified Bodies in conducting an effective assessment of clinical data and clinical evaluations. One is better known than the other. This article discusses both documents and their usefulness in ensuring acceptable clinical eva...
European Medical Device Usability Requirements
Manufacturers marketing medical devices in Europe need to be able to demonstrate compliance with the newly clarified usability requirements introduced by Directive 2007/47/EC. This article discusses European usability requirements, relevant European standards and important ethical considerations.
In Vitro Diagnostic Performance Evaluation Studies: Part 2
In vitro diagnostic medical devices are extremely important healthcare products for which performance evaluation studies can provide necessary evidence on safety and performance. Part 1 of this two-part article discussed European requirements related to performance evaluation studies. Part 2 dis...
In Vitro Diagnostic Performance Evaluation Studies: Part 1
In vitro diagnostic medical devices are extremely important healthcare products for which performance evaluation studies can provide necessary evidence on safety and performance. Part 1 of this two-part article discusses European requirements related to performance evaluation studies. Part 2 will di...
Serious Adverse Event Reporting During European Device Clinical Investigations
In December 2010, two new European guidelines on medical device clinical studies were published. One covers serious adverse event (SAE) reporting while the other provides guidance on when clinical investigations should be conducted, together with general principles to be observed when conducting suc...
Clinical Studies in Italy
The requirements for conducting medical device clinical studies in Europe are not identical in all Member States. That is, variations exist in the way that the requirements in the European Directives are interpreted and enforced. This article provides an overview of the requirements that currentl...
US Regulation of Combination Products
The successful launch of a combination product in the United States (US) will depend on how well a company understands applicable US regulations and policies, which differ in important ways from requirements in Europe. This article provides an overview of useful information on the US regulation of t...
New European Guidance on Borderline Products
The European Commission has recently updated an important guidance document on determining whether or not a medical product is subject to medical device or medicinal product regulations. In addition, a new manual that provides practical examples has also been issued. This article discusses these doc...
Meeting US and European Supplier Control Requirements
Medical device manufacturers operating under European quality system requirements are sometimes surprised to learn that their supplier control procedures do not fully meet United States (US) requirements. This article discusses important differences between US and European requirements for controlli...
Developments Across the Industry
Directive threatens the future of MRI
The European Commission (EC) is under pressure to amend the Physical
Agents (EMF) Directive, which if adopted into national legislation in its
current form, would restrict the use of MRI scanners in medical practice
and research. The...
Avoiding Surprises When Implementing a Single Quality System
European medical device manufacturers are sometimes surprised to learn that operating ISO 13485 alone is not sufficient to meet United States (US) quality system requirements. This article discusses important considerations for meeting US and European requirements when operating under a single quali...
Addressing European Environmental Legislation
Medical device companies need to meet European requirements designed to protect the environment. The deadlines for some of the requirements have already passed. This article discusses a European Regulation and two Directives, and a means for meeting environmental requirements in an effective manner.
The Evolving Process of European Combination Product Review, Part II
A new European guideline on drug-eluting stents (DES)1 introduces for the first time detailed information that European drug authorities should review concerning the medicinal substance that is incorporated into this type of drug–device combination product. Part I of this article discussed Eur...
The Evolving Process of European Combination Product Review, Part I
A new European guideline on drug-eluting stents (DES)1 introduces for the first time detailed information that European drug authorities should review concerning the medicinal substance that is incorporated into this type of drug-device combination product. Part I of this article discusses European ...
Addressing US and European Device Testing Requirements
Medical device companies do not always realise that United States and European test requirements can be significantly different. Not addressing these differences can be costly when retesting or device redesign becomes necessary. This article discusses some of these differences and ways to help avoid...
Clinical Evaluations and Clinical Investigations Under the Amended Medical Device Directive
Directive 2007/47/EC1 amends the earlier Medical Device and Active Implantable Medical Device Directives. Amongst its new requirements is the need for more clinical data and more frequent clinical investigations in the conformity assessment of innnovative medical devices. Details of the changes and ...
New Italian Device Registration Requirements
A medical device manufacturer located outside Europe was informed by an Italian distributor that the European Authorised Representative must designate the distributor as the authorised entity when registering the manufacturer’s devices in Italy in a new online data bank. This is incorrect. Thi...