Standards, Legislation and other related documents

NEW! Documents on the MDR – Medical Device Regulation!

Checklist by the MHRA (UK Medicines and Healthcare products Regulation Agency) on how to comply with the MDR

• MHRA-Checklist on the MDR „Implementation of the Medical Devices EU-Regulation – Focus On Manufacturers‘ Obligations.“

Regulations

• NEW: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 andRegulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/383/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin

Directives and Recommendations

• German Ministry of Health (BMG) – Publication On Unannounced Audits
• Commission Recommendation of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices
• Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending the 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
• Directive 2001/104/EC of the European Parliament and of the Council of 7 December 2001 amending Council Directive 93/42/EEC concerning medical devices
• Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma
• Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

Guidelines

• Guidelines relating to medical devices Directives (MEDDEV documents)

Medical Device Single Audit Program (MDSAP) – Documents

• • Checkliste MDSAP- ISO 13485:2003
  • Checkliste MDSAP – ISO 13485:2016

CoC – Code of Conduct for Notified Bodies

• • • Code of Conduct for Notified Bodies under Directives 90/385/EEC, 93/42/EEC and 98/79/EC, EU 2017/745 and EU 2017/746