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Guidelines relating to

Medical Devices Directives

We present here a compendium of MEDDEV  and NBMED documents for your info.

These  guidelines have been elaborated through a process of consultation with  Competent Authorities and Commission representatives, Notified Bodies, industry and other interested parties in the medical devices sector

Due to the participation of the aforementioned interested parties and of experts from Competent Authorities, it is anticipated that the guidelines will be followed within the Member States and, therefore, ensure uniform application of relevant Directive provisions. Guidelines are subject of a regular updating process.

 

We also follow here the new documents result of the meetings of experts.

 Please return frequently to be up to date.

Guías de las

Directivas Productos Sanitarios

Presentamos aquí un compendio de los documentos MEDDEV  y NBMED para su información.

Estas guías han sido elaboradas vía un proceso de consultas con las Autoridades Competentes y representantes de la Comisión, Organismos Notificados, la industria y otras partes interesadas en el sector de productos sanitarios.

Debido a la participación de las  mencionadas partes interesadas y de expertos de las Autoridades Competentes, se prevé que estas directrices se seguirán en los Estados Miembros y por lo tanto, asegura una aplicación uniforme de las disposiciones de la directiva. Las Guías están sujetas a un proceso regular de actualización.

Seguimos ,además, aquí los nuevos documentos resultado de las reuniones de los expertos.

 Por favor, vuelva frecuentemente para estar al día.

 

LIST MED DEV and NB-MED Rec DOCUMENTS

TITLE of MEDDEV / NB-MED RECOMMENDATION

MEDDEV
NB-MED Rec
1. COUNCIL  DIRECTIVES

1.1

 Council directive 90/385/EEC on active implantable medical devices (AIMD)  

1.2

 Council directive 93/42/EEC on medical devices (MDD  

1.3

 Council directive 98/79/EEC on in vitro diagnostic medical devices (IVD)  
2. GUIDANCE DOCUMENTS

2.1
Scope, field of application, definition

Definitions of "medical devices", "accessory" and "manufacturer"

2.1/1 

April-1994
Field of application of directive "active implantable medical devices" 2.1/2 rev 2

April-1994
Treatment of computers used to program implantable pulse generators 2.1/2.1

Feb-1998
Interface with other directives - Medical devices/medicinal products 2.1/3 rev 2

Jul-2001
Interface with other directives - Medical devices/directive89/336/EEC relating to electromagnetic compatibility and directive 89/686/EEC relating to personal protective equipment 2.1/4

Mar-1994
Medical devices with a measuring function 2.1/5

Jun-1998
Representative sample 2.1/Rec1
Explanation of terms 2.1/Rec2
Accessories and other parts for AIMD 2.1/Rec3
Medical devices with a measuring function 2.1/Rec4
Placing on the market of fully refurbished medical devices 2.1/Rec5
2.2
Essential requirements		 EMC requirements

NB-MED EMC requirements

 2.2/1 rev 1

Feb-1998

 

2.2/Rec1
"Use by" - date 2.2/3 rev 3

Jun-1998
Treatment of computer used to program Active Implantable Medical 2.2 /Rec2
Software and Medical Devices 2.2/Rec4
2.3
Reference to standards		 Publication of titles and references of european harmonized standards under AIMD and MDD 2.3/1
2.4
Classification of MD		 Guidelines to the classification of medical devices part 1  2.4/1 rev. 8

jul-2001

Guidelines to the classification of medical devices part 2

 2.4/1 part2  rev.8

Jul-2001

2.5
Conformity assessment procedure

General rules

Content of mandatory certificates

 2.5.1/Rec4
Technical documentation 2.5.1/Rec5
Renewal of EC Design- Examination and type-Examination certificates 2.5.1/Rec6
Quality assurance Regulatory auditing of quality systems of medical devices manufacturers 2.5/2 rev 3

Jun 1998
Subcontracting quality system related 2.5/3 rev.2

Jun-1998

Reporting of design changes and of changes of the quality system

 2.5.2/Rec2

Translation procedure

 2.5/5 rev.3
feb 1998

Homogenous batches (verification of manufacturers’ products)

 2.5/6 rev.1
feb 1998

2.5
Conformity assessment procedure

 

Conformity assessment for particular groups of products

 

Conformity assessment of breast implants

 2.5/7 rev.1

Jul-1998

Evaluation of medical devices incorporating products of animal origin

 2.5/8 rev.2

Feb-1999
Evaluation of medical devices incorporating products containing natural rubber latex 2.5/9 rev1

Feb-2004
2.5.2
Quality assurance		 Subcontracting- QS related 2.5.2/Rec1
Reporting of design  changes and changes of quality system 2.5.2/Rec2
Translation procedure 2.5.2/Rec3
2.5.3
Type examination		    
2.5.4
Verification of manufactured products		 Homogeneous batches 2.5.4/Rec1
Verification of manufacture products for IVD directive 2.5.4/Rec2
2.5.5
Conformity assessment for particular product groups		 Conformity assessment procedures of breast implants 2.5.5/Rec1
Combination of CE marked and non CE marked medical devices and non-medical devices 2.5.5/Rec2
Conformity assessment of annex II, IVD designed and evaluated prior to adoption of CTS 2.5.5/Rec3
Assessment of sensitivity of IVD Medical devices- Guidance on the application of the CTS 2.5.5/Rec4
2.6
CE marking		    
2.7
Clinical investigation, clinical evaluation		 Guide for manufacturers and notified bodies 2.7.1

Apr-2003
Evaluation of clinical data 2.7/Rec3
2.8
Devices intended for special purposes		    
2.9
Systems and procedure packs		    
2.10
Notified bodies		 Designation and monitoring of Notified Bodies within the framework of EC Directives on Medical devices

2.10/2 rev. 1

Apr-2001
Annex 1
Annex 2
Annex 3
Annex 4
2.11
Products using materials of biological origin

Application of council Directive 93/42/EEC taking into account the Commission
Directive 2003/32/EC for Medical Devices utilizing tissues or derivatives originating from animals for which a TSE risk is suspected

2.11/1 rev.1

Feb-2004

Annex 1
2.12
Market surveillance ; vigilance		 Medical devices vigilance system (OBSOLETE replaced by rev 5) 2.12/1 rev.4
apr 2001
Medical devices vigilance System 2.12/1 rev5 apr 2007
Appendix, list of contact points 2.12/1 rev 4
nov 2001
Clinical Evaluation - Post Market Clinical Follow-up 2.12/2
may 2004
Post-Marketing Surveillance (PMS) post market/production 2.12/Rec1
2.13
Transitional period		 OJ C242 of August 8, 1998

2.13 rev.1
CE-Marking of pre-MDD devices 2.13/Rec1
CE-Marking of established IVD devices 2.13/Rec2
2.14
Implementation		 Implementation of AIMD Directive into national law 2.14/1
Implementation of MD Directive into national law 2.14/2
Implementation of IVDMD Directive into national law 2.14/3
2.14

IVD

 Borderline issues

2.14/1 rev.1

Jan-2004
Research Use Only products 2.14/2 rev.1

Feb-2004
Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices 2.14/3 rev.1
jan - 2007
 

2.15
Other guidance

 Committees, working parties relevant for medical devices

2.15 rev.2

Jul-2001
Global Harmonization Task Force 6/94 p.1
6/94 p.2
Voluntary certification at an intermediate stage of manufacture 2.15/Rec1
3. CONSENSUS STATEMENTS
“Consensus statements“ on Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC

NB-MED CONSENSUS STATEMENTS

completed by comments of the Notified Body Recommendations Group - NBRG   Issue 01/2003

The "consensus statements“ :

(i)      reflect consensus of those present / represented at the time of the relevant meeting Note: Opinion may change in the light of experience and / or detailed considera­tion of the issue, for example, by those involved in drafting „Recommenda­tions“ in the area, and thus a particular „statement“ may be superseded.

 (ii)     may take the form of questions and answers, often qualified in relation to specific circumstances, products etc.

Note: The answer given may not be appropriate to other circumstances, products etc.

(iii)    will include text in italics below each „statement“ 

(a)     indicating the actions agreed as necessary that are planed or have been taken

(b)     referring to specific relevant NB-MED „Recommendation(s)“ in the area

(c)     indicating where a „statement“ has been superseded, with appropriate cross-references

NBRG/276/03

S/01/95

Subcontracting of design and production

S/02/95

Demarcation with Medical Laboratory Equipment

S/03/95

European representative from manufacturers from outside the Community

S/04/95

Expiration date on packaging for sterile products

S/05/95

Packaging for instruments sterilized by the user

S/06/95

Product testing as part of the surveillance of QS

S/01/96

Validation of the technical documentation as part of auditing under Annex V and VI

S/02/96

Classification of ear thermometers

S/03/96

Authorized representative

S/04/96

CE marking of refurbished devices

S/05/96

CE marking of class I devices

S/06/96

Declaration of reversed osmotic systems

S/07/96

Classification of devices for disinfecting, cleaning, rinsing, hydrating

S/08/96

Quality systems in case of complete subcontracting

S/09/96

Beautician equipment

S/10/96

Road motor vehicle for handicapped persons

S/11/96

CE marking of separate sold devices

S/12/96

Oven in dental laboratories

S/13/96

Time limits of certificates

S/14/96

Certification of subcontractor

S/01/97

Nasal rinsing and humidifying solutions; Classification

S/02/97

Custom-made mouth guards; Classification

S/03/97

Laser equipment; Classification

S/04/97

Gas distribution networks in hospitals

S/05/97

Borderline products between medical devices and home training devices, or devices for comfort, or cosmetic devices

S/06/97

Classification of surgical instruments

S/07/97

Status of coatings of implants

S/08/97

Withdrawal or refusal of certificates

S/09/97

Classification of dialysis concentrates

S/10/97

Quality certificates for single products

S/11/97

OEM Products; certification

S/12/97

Certification of class IIb products in combination of Annexes II and V of the MDD

S/13/97

Hearing aids

S/14/97

Programmable electrical Medical Systems

S/15/97

Classification of a medical-diagnostic device for determining woman’s fertile and infertile period

S/16/97

Resuscitation masks; categorisation

S/17/97

Wigs and toupees; Classification

S/18/97

Arms rests installed in buildings for handicapped persons; Classification

S/19/97

Brushers with disinfectants for use by healthcare personnel; Classification

S/20/97

Software programmes used for patients to provide rehabilita­tion; Classification

S/21/97

Products made from latex

S/22/97

Data Management and Exchange

S/23/97

Storage solutions for organs; classification

S/24/97

Complex salt solution for irrigation; classification

S/25/97

Independence of the auditors

S/26/97

Products in the distribution chain and the impact of that in relation to the end of the transition period

S/27/97

Categorisation of devices for preparation of solution bags¡

S/28/97

Declaration specifying that no application has been lodged with any other Notified Body for the same product/product related quality system

S/29/97

Categorisation of thermosealing machine

S/30/97

Are devices for storage of blood, human cells and sperm which are determined to be returned to the human body medical devices or not?

S/31/97

Devices for use in heart surgery; Classification

S/32/97

Gloves; Classification

S/33/97

Nebulizers (used to administer a medicinal product, which was potentially hazardous in reference to rule II, annex II) ; Classification

S/34/97

Products intended for rinsing; Classification

S/35/97

Storage solutions for organs; Classification

S/36/97

Complex salt solution for irrigation; Classification

S/37/97

Proteins - produced by genetic means - which are used with devices for bone repairing

S/38/97

Dental filling material

S/39/97

Products made from latex

S/01/98

Demarcation Medical Devices, Accessories and Production or Laboratory Devices

S/02/98

Lasers for skin treatment (low level laser therapy); classifica­tion

S/03/98

Samples of certificates

S/04/98

Blood bags with preservation solution

S/05/98

Decoupling of certificates

S/06/98

Medical gas pipeline systems in hospitals

S/07/98

Retention periods for documents and quality records

S/08/98

Sterile patient drapes; Classification

S/09/98

Oximeter; Classification

S/10/98

Auditing of internal audits performed by a manufacturer within his QS

S/11/98

Gases for driving medical tools

S/12/98

Blood bags with preservation solution

S/13/98

Own brand labelling

S/14/98

Refillable glass capsule containing sodium-hydrogen car­bonate (used to produce a bicarbonate solution during dialy­sis)

S/15/98

Surveillance - Inability to carry out unannounced visits in Non-EU States

S/16/98

Sterilisation of reusable medical devices

S/17/98

Low pressure regulators; Classification

S/18/98

Sterilizers used for final sterilisation of medical devices to be put on the market

S/19/98

Re-use of single use devices

S/01/99

Declaration of conformity

S/02/99

Software; Classification

S/03/99

Pools for training disabled persons

S/04/99

Free movement, device intended for special purpose

S/05/99

Carotid shunt; Classification