Article 4.Free movement, devices intended for special purposes
Article 7.(1) The Commission shall be assisted by the Committee set...
Article 10.Information on incidents occuring following placing of devices on the market
Article 12. Particular procedure for systems and procedure packs and procedure for sterilisation
Article 13. Decisions with regard to classification and derogation clause
Article 14.Registration of persons responsible for placing devices on the market
Article 23.This Directive is addressed to the Member States.
1. The devices must be designed and manufactured in such a...
2. The solutions adopted by the manufacturer for the design and...
3. The devices must achieve the performances intended by the manufacturer...
4. The characteristics and performances referred to in Sections 1, 2...
5. The devices must be designed, manufactured and packed in such...
6. Any undesirable side-effect must constitute an acceptable risk when weighed...
6a. Demonstration of conformity with the essential requirements must include a...
II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION
7. Chemical, physical and biological properties
7.1. The devices must be designed and manufactured in such a...
7.2. The devices must be designed, manufactured and packed in such...
7.3. The devices must be designed and manufactured in such a...
7.4. Where a device incorporates, as an integral part, a substance...
7.5. The devices must be designed and manufactured in such a...
7.6. Devices must be designed and manufactured in such a way...
8. Infection and microbial contamination
8.1. The devices and manufacturing processes must be designed in such...
8.2. Tissues of animal origin must originate from animals that have...
8.3. Devices delivered in a sterile state must be designed, manufactured...
8.4. Devices delivered in a sterile state must have been manufactured...
8.5. Devices intended to be sterilized must be manufactured in appropriately...
8.6. Packaging systems for non-sterile devices must keep the product without...
8.7. The packaging and/or label of the device must distinguish between...
11. Protection against radiation
12. Requirements for medical devices connected to or equipped with an...
12.1. Devices incorporating electronic programmable systems must be designed to ensure...
12.1a For devices which incorporate software or which are medical software...
12.2. Devices where the safety of the patients depends on an...
12.3. Devices where the safety of the patients depends on an...
12.4. Devices intended to monitor one or more clinical parameters of...
12.5. Devices must be designed and manufactured in such a way...
12.7. Protection against mechanical and thermal risks
12.7.1. Devices must be designed and manufactured in such a way...
12.7.2. Devices must be designed and manufactured in such a way...
12.7.3. Devices must be designed and manufactured in such a way...
12.7.4. Terminals and connectors to the electricity, gas or hydraulic and...
12.7.5. Accessible parts of the devices (excluding the parts or areas...
12.8. Protection against the risks posed to the patient by energy...
12.9. The function of the controls and indicators must be clearly...
13. Information supplied by the manufacturer
13.1. Each device must be accompanied by the information needed to...
13.2. Where appropriate, this information should take the form of symbols....
13.4. If the intended purpose of the device is not obvious...
13.5. Wherever reasonable and practicable, the devices and detachable components must...
13.6. Where appropriate, the instructions for use must contain the following...
1. The manufacturer must ensure application of the quality system approved...
2. The EC declaration of conformity is the procedure whereby the...
1. The EC declaration of conformity is the procedure whereby the...
2. The manufacturer must prepare the technical documentation described in Section...
3. The technical documentation must allow assessment of the conformity of...
4. The manufacturer shall institute and keep up to date a...
5. With products placed on the market in sterile condition and...
STATEMENT CONCERNING DEVICES FOR SPECIAL PURPOSES
1. For custom-made devices or for devices intended for clinical investigations...
3. The manufacturer must also undertake to keep available for the...
4. The information contained in the declarations concerned by this Annex...
5. For custom-made devices, the manufacturer must undertake to review and...
1.1. As a general rule, confirmation of conformity with the requirements...
1.1a In the case of implantable devices and devices in Class...
1.1b The clinical evaluation and its outcome shall be documented. This...
1.1c The clinical evaluation and its documentation must be actively updated...
1.1d Where demonstration of conformity with essential requirements based on clinical...
1.2. All the data must remain confidential, in accordance with the...
2.3.1. Clinical investigations must be performed on the basis of an...
2.3.2. The procedures used to perform the investigations must be appropriate...
2.3.3. Clinical investigations must be performed in circumstances similar to the...
2.3.4. All the appropriate features, including those involving the safety and...
2.3.5. All serious adverse events must be fully recorded and immediately...
2.3.6. The investigations must be performed under the responsibility of a...
2.3.7. The written report, signed by the medical practitioner or other...