Obelis Attends Inauguration of CURAM (Center for Research in Medical Devices)
News

Obelis Chief Compliance Officer, Mrs. Sandra Ferretti, participated in the official inauguration of CURAM – Center for Research in Medical Devices, which took place on Monday, the 26th of Septemb [...]

MEDDEV 2.7/1 – new guidelines on clinical evaluations
News

On the 29th of June 2016, the European Commission released a new version of MEDDEV 2.7/1, entitled “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directive 93/42/EEC and [...]

EU to release NEW Medical Device Regulations!
News

In June 2016, the European Parliament released the consolidated texts of the new EU Regulation Proposals on Medical Devices and In-Vitro Diagnostics Devices. The texts, published on the European Par [...]

New Medical Devices and In-Vitro Diagnostic Regulations – Status of the Ongoing Discussions
News

The approval of the new EU Regulations on Medical Devices and In-Vitro Diagnostics Devices will be postponed to 2016. (more…) [...]

Legislation

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


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


Other Applicable Legislation

in Legislation

(EU) No 920/2013
⇨ On the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices


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