Legislation
NBOG
⇨ CERTIFICATES ISSUED BY NOTIFIED BODIES REFERENCE TO COUNCIL DIRECTIVES 2010-3
⇨ GUIDANCE FOR NOTIFIED BODIES AUDITING SUPPLIERS
⇨ GUIDANCE ON AUDIT REPORT CONTENT
⇨ CHECKLIST FOR AUDIT OR NOTIFIED BODY REVIEW OF CLINICAL DATA/EVALUATION
GHTF
PART 4
⇨ GUIDELINES FOR MULTI-SITE AUDITING OF QMS
PART 5
⇨ GUIDELINES FOR AUDITING MFG CONTROL OF SUPPLIER
New Regulation (EU) 2017/746 on In-Vitro Diagnostic Devices
IVDR 217/746
⇨ In-Vitro Diagnostics Devices Regulation
New Regulation (EU) 2017/745 on Medical Devices
MDR 2017/745
⇨ Medical Devices Regulation
Information Platform on EU Medical Devices Regulation
⇨ MDlaw.eu
Medical Devices and Active Implantable Medical Devices
90/385/EEC
⇨ Active Implantable Medical Devices Directive
93/42/EEC
⇨ Medical Device Directive
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
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
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
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
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
Open Applicable Legislation
Recommendation 2013/473/EU
⇨ On the audits and assessments performed by notified bodies in the field of medical devices
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 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