MDD 2007 47 EC...
Medical Devices Directives 2007 47 EC and MDD 93/42/EEC
Information & Training. | Medical Devices.
Directive 2007/47/EEC was published in the Official Journal of the EU in 2007, compliance became mandatory from 21st March 2010. The amendments impacted the following Directives:
FDA cGMP’s. EU MDR’s / MDD’s.
FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
FDA Medical Device Classification. The FDA approach to Medical Device Classification.
EU Medical Device Regulation and Classification (per MDD’s).
New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
Quality System requirements to maintain compliant Validations.
Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
Medical Device Software Validation.
Medical Device Design Validation.
Electronic Signature, Electronic Records.
Life Cycle Approach to Validation.
Risk Identification. Documentation. DHR’s. DMR’s.
Etc. Etc. …
Information & Training presentation >>>
Medical Device Directive 93/42/EEC,
Active Implantable Medical Devices Directive 90/385/EEC and
Biocidal Products Directive 98/8/EC.
The major areas of change are as follows:
Clinical data. Is required for all devices regardless of classification, i.e. this now includes all Class 1 devices.
Custom made devices. These need to comply with post market production review systems as regards incident reporting. In addition, patients who receive custom made devices need to be provided with minimum levels of information. There are also additional requirements related to customer made devices and Clinical Devices incorporating animal tissues and human blood derivatives
Records. Manufacturers must retain their records for 5+ years from date of manufacture, or for the “useful life” of the product which ever is greater, for review by the competent authorities.
Indications for use. It is required that the manufacturer clearly indicates the date of issue or the latest revision of the instructions for use.
Clarification of single use. The manufacturer’s indications regarding single use must be consistent across the European Union markets.
Single use devices need to include information on risks associated with device re-use.
EU authorized representative. It is required that the designation of the authorized representative should cover all devices of the same model.
Classification. Devices are classified based on their “primary mode of action” and not by their “intended use”. This approach also applies to the classification of a Drug / Device combination product. An example is a pre-filled syringe containing a drug. Under “intended use” it could be considered a device (syringe) or a drug, however under “primary mode of action” it is clearly a drug.
Designation as Class III. All surgically invasive devices intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body are classified as Class III devices.
Software. Is considered an active medical device, whether integral with the device or as a stand-alone product. Software validation will also be an Essential Requirement in Annex I.
Definition of “continuous use”. Under MDD 2007 47 EC includes situations in which a device, upon discontinuation or removal, is replaced immediately by the same or with an identical device.
Technical Files need to include pre-clinical data.
PPE. Medical Devices that also protect the user, must simultaneously be assessed against the requirements of the Personal Protective Equipment Directive 89/686/EEC.
Post Market Surveillance needs to include trend reporting. Foetal distress or death, congenital abnormality, birth defects are required to be reported as incidents/accidents.
Document Management needs to include the “Declaration of Conformity” and “Instructions for Use” documents.
The Quality Management System needs to include procedures covering post market surveillance and Risk Management of the device.
Notified Bodies may place greater focus on third party contractors.
Information & Training.
Medical Device:
- Validation. Classification. Regulation. Requirements. Current best practices.
- FDA cGMP’s. EU MDR’s / MDD’s.
- FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
- FDA Medical Device Classification. The FDA approach to Medical Device Classification.
- EU Medical Device Regulation and Classification (per MDD’s).
- New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
- Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
- Quality System requirements to maintain compliant Validations.
- Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
- Medical Device Software Validation.
- Medical Device Design Validation.
- Electronic Signature, Electronic Records.
- Life Cycle Approach to Validation.
- Risk Identification. Documentation. DHR’s. DMR’s.
- Etc. Etc. …
- Information & Training presentation >>>
EU Commission interpretation on 2007/47/EC