Legislation

NBOG

in Legislation

NBOG
⇨ CERTIFICATES ISSUED BY NOTIFIED BODIES REFERENCE TO COUNCIL DIRECTIVES 2010-3

NBOG
⇨ GUIDANCE FOR NOTIFIED BODIES AUDITING SUPPLIERS

NBOG
⇨ GUIDANCE ON AUDIT REPORT CONTENT

NBOG
⇨ CHECKLIST FOR AUDIT OR NOTIFIED BODY REVIEW OF CLINICAL DATA/EVALUATION


GHTF

in Legislation

EU – GHTF – PART 4
⇨ GUIDELINES FOR MULTI-SITE AUDITING OF QMS

EU – GHTF – PART 5
⇨ GUIDELINES FOR AUDITING MFG CONTROL OF SUPPLIER


New Regulation (EU) 2017/746 on In-Vitro Diagnostics Devices

in Legislation

IVDR 217/746
⇨ In-Vitro Diagnostics Devices Regulation


New Regulation (EU) 2017/745 on Medical Devices

in Legislation

MDR 2017/745
⇨ Medical Devices Regulation


Medical Devices and Active Implantable Medical Devices

in Legislation

90/385/EEC
⇨ Active Implantable Medical Devices Directive

93/42/EEC
⇨ Medical Device Directive

2007/47/EC
⇨ Amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

2005/50/EC
⇨ Reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices

2003/12/EC
⇨ On the reclassification of breast implants in the framework of Directive 93/42/EEC concerning
medical devices

(EU) No 207/2012
⇨ On electronic instructions for use of medical devices

(EU) No 722/2012
⇨ Concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin

2003/32/EC
⇨ Introducing detailed specifications as regards the requirements laid down in Council Directive 93/
42/EEC with respect to medical devices manufactured utilising tissues of animal origin

Recommendation 2013/172/EU
⇨ On a common framework for a unique device identification system of medical devices in the Union

 


In Vitro Diagnostic Medical Devices

in Legislation

Directive 98.79.EC
⇨ Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

Commission Directive 2011/100/EU
⇨  Commission Directive 2011/100/EU – OJ L341/50 of 22.12.2011

Commission Decision 2011/869/EU
⇨ Commission Decision 2011/869/EU – OJ L341/63 of 22.12.2011

Commission Decision 2002/364/EC
⇨  Commission Decision 2002/364/EC – OJ L131/17 of 16.05.2002

Commission Decision 2009/886/EC
⇨ Commission Decision 2009/886/EC – OJ L318/25 of 14.12.2009

 Corrigendum to Commission Decision 2009/886/EC
⇨ Corrigendum to Commission Decision 2009/886/EC – OJ L 348/94 of 29.12.2009


MEDDEV

in Legislation

 MEDDEV 2.5/10
⇨ GUIDELINE FOR AUTHORISED REPRESENTATIVES

MEDDEV 2.7/1 Rev.4
⇨ CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC

MEDDEV 2.1/1
⇨ DEFINES MEDICAL DEVICES, ACCESSORIES AND MANUFACTURER

MEDDEV 2.12/2 Rev.2
⇨ POST MARKET CLINICAL FOLLOW UP FOR MEDICAL DEVICES

MEDDEV 2.12/1 Rev. 1
⇨ EMC REQUIREMENTS

MEDDEV 2.2/3 Rev. 3
⇨ USE-BY DATE

MEDDEV 2.2/4
⇨ CONFORMITY ASSESSMENT OF IVF AND ART PRODUCTS

MEDDEV 2.4/1 Rev. 9
⇨ CLASSIFICATION OF MEDICAL DEVICES

MEDDEV 2.5/6 Rev. 1
⇨ HOMOGENEITY OF PRODUCTION BATCHES

MEDDEV 2.5/9 Rev. 1
⇨ MEDICAL DEVICES CONTAINING NATURAL RUBBER LATEX

MEDDEV 2.7/2
⇨ VALIDATION/ASSESSMENT OF A CLINICAL INVESTIGATION APPLICATION UNDER DIRECTIVES 93/42/EEC & 90/385/EEC

MEDDEV 2.7/4
⇨ CLINICAL INVESTIGATION

MEDDEV 2.5/7 Rev. 1
⇨ CONFORMITY ASSESSMENT FOR BREAST IMPLANTS

MEDDEV 2.1/2.1
⇨ TREATMENT OF COMPUTERS USED TO PROGRAM IMPLANTABLE PULSE GENERATORS

MEDDEV 2.1/6
⇨ QUALIFICATION AND CLASSIFICATION OF STAND ALONE SOFTWARE

MEDDEV 2.11/1 Rev. 2
⇨ RISK MANAGEMENT IN ANIMAL TISSUE PRODUCTS – TSE

MEDDEV 2.14/4
⇨ CE MARKING OF BLOOD BASED IVD MEDICAL DEVICES FOR VCJD

MEDDEV 2.7/3
⇨ CLINICAL INVESTIGATIONS: SERIOUS ADVERSE EVENT REPORTING

MEDDEV 2.14/1 Rev. 2
⇨ IVD BORDERLINE AND CLASSIFICATION ISSUES

MEDDEV 2.1/3 Rev. 3
⇨ BORDERLINE PRODUCTS: DRUG DELIVERY PRODUCTS AND MEDICAL DEVICES

MEDDEV 2.12/1 Rev. 8
⇨ MEDICAL DEVICES VIGILANCE SYSTEM


Guidance Documents

in Legislation

Guidance Notes for Manufacturers of Class I Medical Devices
⇨ Guidance Notes for Manufacturers of Class I Medical Devices endorsed by the MDEG on December 2009

Relation between 93/42/EEC and 89/686/EEC
⇨ Relation between the revised Directive 93/42/EEC concerning medical devices and Directive 89/686/EEC on personal protective equipment

Guidance Notes for Manufacturers of Custom-Made Medical Devices
⇨ Guidance Notes for Manufacturers of Custom-Made Medical Devices endorsed by the MDEG on June 2010

Guidance document on Dir. 2005/50/EC
⇨ Guidance document on Dir. 2005/50/EC endorsed by the MDEG on December 2006

IVD Trisomy 21
⇨ IVD Trisomy 21 endorsed by the MDEG on December 2006

IVD Rare Blood Groups
⇨ IVD Rare Blood Groups endorsed by the MDEG on December 2003

Interpretation of 2007/47/EC
⇨ Interpretation of implementation of Directive 2007/47/EC

Manual on Borderline Classification
⇨ Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices

EU Commission Recommendation
⇨ EU Commission Recommendation Regarding Unannounced Audits


Other Applicable Legislation

in Legislation

Recommendation 2013/473/EU
⇨ On the audits and assessments performed by notified bodies in the field of medical devices


COM(2012) 540
⇨ Communication on safe, effective and innovative medical devices and in vitro diagnostic medical devices for the benefit of patients, consumers and healthcare professionals
.


PROPOSALS FOR A REGULATION


Proposal for a Regulation for MDD
⇨ Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009


Proposal for a Regulation for IVD
⇨ Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices


EXTERNAL WEBSITES


Interpretative Documents
⇨ Interpretative Documents


Medical Devices Harmonized Standards
⇨ Medical Devices Harmonized Standards


In Vitro Diagnosis Harmonized Standards
⇨ In Vitro Diagnosis Harmonized Standards


Active Implantable Medical Devices Harmonized Standards
⇨ Active Implantable Medical Devices Harmonized Standards