On 21 March 2010, the revisions to Medical Device Directive 93/42 EEC and Active Implantables Medical Device Directive 90/385/EEC will become law. The most important changes apply to the clinical data and design documentation requirements for all classes of devices. Manufacturers of Class IIa devices will be especially affected because they are audited by a notified body. However, this change will also have an impact on manufacturers of Class I devices through their ISO 13485:2003 audit or when a competent authority inspects their technical files on the premises of their European authorized representative. Guidance documents and secondary legislation should be developed to ensure that the new provisions are adequately implemented, but March 2010 is right around the corner, and we have yet to see any such guidance. As it stands, these measures apply to current CE marked devices as well as new devices. Our hope is that guidance will lighten the burden on existing products.
In addition to these new requirements, which we may address in future issues of the Consultants Corner newsletter, several other changes have been introduced into the new directive. To help you understand how these revisions may impact your European operations, here is part 1 of a comprehensive glossary compiled by MediMark Europe. Part two will be published in the June issue of this newsletter. We sincerely hope that you find it helpful.
Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorized representative in the European Union. This designation should be effective at least for all devices of the same model. (In the previous version of the directive, this was phrased as follows: “the person(s) who is (are) responsible for marketing them who is (are) established in the Community.”)
The definition of central circulatory system has been extended to the aorta arcus and aorta descendens to the bifurcatio aortae. Any products coming into contact with these vessels are now considered to be Class III products. Devices that come in direct contact with the central nervous system are also in Class III. Surgically invasive device intended to have a biological effect or to be wholly or mainly absorbed are in Class IIb (previously, they were Class III). Also, devices that are specifically used to disinfect invasive (my emphasis) devices are now in Class IIb instead of Class IIa. Finally, invasive devices designed to connect to an active Class 1 medical device are now also Class I devices. Previously, they were not classified.
Class 1 Compliance Module
Manufacturers of Class I sterile devices and/or devices with a measuring function have the option of using the full quality assurance conformity assessment module (Annex II). Manufacturers who chose Annex II for their other higher class devices will no longer need to have a separate EC Certificate (Annex V).
Clinical Data Required for All Device Classifications
Clinical data will be required for all devices, even those in the lowest risk Class I category. The essential requirements include a new section 6a: Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X, which states that the characteristics and performance under normal conditions of the use of the device, and the evaluation of the side effects and of the acceptability of the benefit/risk ratio referred to in Section 6 of Annex I, must be based on clinical data. (The phrase “in particular in the case of long term implantable devices and Class III” has been removed.)
The evaluation of this data, (or clinical evaluation), taking account of any relevant harmonized standards, must follow a defined and methodologically sound procedure based on:
either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics, and intended purpose of the device, where:
or a critical evaluation of the results of all clinical investigations made;
or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.
The clinical evaluation and its documentation must be actively updated using postmarket surveillance data. Where postmarket clinical follow-up as part of the postmarket surveillance plan for the device is not deemed necessary, this must be duly justified and documented.
Where demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, adequate justification for any such exclusion has to be given based on risk management output and under consideration of the specifics of the device-body interaction, the clinical performances intended, and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential requirements by performance evaluation, bench testing, and preclinical evaluation alone has to be duly substantiated.
Competent Authorities and Confidentiality
Adverse events reported to the competent authorities and information contained in certificates issued, modified, supplemented, suspended, or withdrawn are excluded from the scope of their confidentiality.
Continuous Use Definition
Continuous use means uninterrupted actual use of the device for the intended purpose. Where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device, this shall be considered an extension of the continuous use of the device.
Control of Third Party Quality Systems
In light of increased use of third parties to carry out the design, manufacture, and/or final inspection and testing of the devices on behalf of the manufacturer, it is important that the manufacturer demonstrate that adequate controls have been applied to the third party to maintain efficient operation of quality systems.
Part two of the glossary covering everything from declaration of conformity to software will be published in the June issue of the Consultants Corner newsletter. Don’t miss an issue: subscribe now!
René Clément is co-chairman of MediMark Europe, which serves as an authorized representative for US manufacturers of medical devices and IVD products. For more information about the firm, visit the company’s listing in the online Consultants Directory, or go to www.medimark-europe.com.