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
.


Regulation (EU) 2017/2185
⇨ On the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices
 
 


GDPR (EU) 2016/679
General Data Protection Regulation (GDPR) (EU) 2016/679


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 Standard