In the previous Consultants Corner newsletter, we published the first part of a comprehensive glossary of revisions to Medical Device Directive 93/42/EEC and Active Implantables Medical Device Directive 90/385/EEC. In this issue, we continue our review of the revisions beginning with changes involving the declaration of conformity.
The revisions will become law on 21 March 2010, and they will have an impact on your European operations. We hope you find this glossary compiled by MediMark Europe to be informative and helpful.
Declaration of Conformity
The declaration of conformity must cover one or more manufactured medical device(s) clearly identified by means of a product name, product code, or other unambiguous reference. The declaration must be kept by the manufacturer. All declarations shall be redone by March 2010 to declare compliance with the requirements of 93/42/EEC "as amended by 2007/47/EC."
Design Documentation Review (All Classes)
Before they can be placed on the market, Class III devices require explicit prior authorization with regard to conformity, including an assessment of the design documentation. It is essential and necessary for the notified body to review design documentation to ensure the manufacturer is in compliance with Directive 93/42/EEC. The depth and extent of this review should be commensurate with the classification of the device, the novelty of the intended treatment, the degree of intervention, the novelty of the technology or construction materials, and the complexity of the design and/or technology. This review can be achieved by taking a representative example of design documentation of one or more types of devices from those being manufactured. Further review(s)—in particular, the assessment of design changes that could affect the product’s conformity with the essential requirements—should be part of the surveillance activities of the notified body.
Device Incorporating a Medicinal Product
Having verified the usefulness of the substance as part of the medical device and taken into account the intended purpose of the device, the notified body shall seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA), acting particularly through its committee in accordance with Regulation (EC) No. 726/2004, on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or EMEA shall take into account the manufacturing process and data related to the usefulness of the substance’s incorporation into the device as determined by the notified body. The opinion of the competent agency or national authority must be drafted within 210 days after receipt of valid documentation
Device Incorporating Blood Derivatives
Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device.
Ergonomic Design in the Essential Requirements
It is necessary to consider ergonomic design in the essential requirements in order to reduce as much as possible user errors caused by the ergonomic features of a device. The technical knowledge, experience, education and training and, where applicable, the medical and physical conditions of the intended users shall be taken into account.
Data related to custom devices are excluded from the databank; data related to clinical investigations are added to its scope. No later than 2012, the Commission shall evaluate the operational functioning and added value of the databank. On the basis of this evaluation, the Commission shall, if appropriate, present proposals to the European Parliament and the Council, or present draft measures.
IFU by Other Means
The new directive does not permit e-labeling but it allows the Commission, where justified, to "adopt measures allowing instructions for use to be provided by other means."
IFU Date of Issue
The date of issue or the latest revision shall appear in the instructions for use.
Devices must be designed and manufactured in such a way as to minimize risks posed by substances leaching from the device. Special attention shall be given to substances that are carcinogenic, mutagenic or toxic to reproduction in accordance with Annex I to Directive 67/548/EEC.
Phthalate-containing devices or parts of a device that are intended to administer and/or remove medicines, fluids, or other substances to or from the body or to transport and store such body fluids or substances must be labelled appropriately. This applies to category 1 or 2 phthalates that are classified as carcinogenic, mutagenic, or toxic to reproduction in accordance with Annex I of Directive 67/548/EEC. DEHP, which is largely used in medical devices, is classified as a category 2 phthalate. The label should be placed on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging.
If the device’s intended use involves the treatment of children or pregnant or nursing women, the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements. In particular, the information on residual risks for these patient groups must appear in the technical documentation and instructions for use. If applicable, appropriate precautionary measures should also be stated.
The Commission should mandate CEN and/or CENELEC to specify technical requirements and a suitable specific label for phthalate-containing devices within 12 months after the Directive’s entry into force.
The manufacturer shall institute and keep current a systematic procedure to review experience gained during the postproduction phase, including provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action.
Data concerning preclinical evaluations are now included in section 3.2 of the Annex II Quality System.
Registration of Class IIa Products
Member States may request all data relevant to the identification of Class IIa, Class IIb, and Class III devices, including the label and instructions for use. Previously, this applied only to Class IIb and Class III devices.
Particular care should be taken to ensure that the reprocessing of medical devices does not endanger a patient’s safety or health. The Commission shall submit a report to the European Parliament and to the Council on the reprocessing of medical devices in the European community three years, at most, after the adoption of this Directive.
Retention of Documentation for Implantables
Administrative documents related to implantable devices must be retained at least 15 years by the manufacturer or the authorized representative.
Serious Adverse Events during Clinical Investigations
All competent authorities of Member States in which a clinical investigation is being performed following a serious adverse event must be immediately notified. (Currently, only the competent authority of the country where the serious adverse event occurred must be notified.)
If the device bears an indication that it is for single use, information about the known characteristics and technical factors that could pose a risk if the device were to be re-used must be added to the instructions for use by the manufacturer. For Class I and Class IIa devices, which do not require instructions for use, the information must be made available to the user upon request.
The definition of a medical device has been broadened to include software, whether it is a stand-alone product or incorporated into another device. Stand-alone software is considered to be an "active medical device." The software must be validated according to state-of-the-art practices taking into account the principles of the development lifecycle, risk management, and verification. General-purpose software used in a healthcare setting is not considered a medical device.
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.