Worldwide, Medical Devices manufacturers, testing organizations, and regulators are working hand in hand to ensure patients can trust in effective and safe Medical Devices any time and anywhere. Improved standards are gradually making this collaboration more effective, step by step.
In keeping with this, at TÜV SÜD we support the international Medical Device Single Audit Program (MDSAP),which aims at establishing uniform minimum standards for testing organizations.
In Europe, the EU Commission enforced the regular conduct of unannounced audits of medical device manufacturers. We discussed this issue with our expert, Hans-Heiner Junker, in a fascinating interview.
In Malaysia new standards are being established and, in parallel, TÜV SÜD has become accredited as a Conformity Assessment Body. In addition, we would like to draw your attention to the new guidance on the ISO 14971 risk management standard and to the Environmental Protection Directive RoHS II. From June 2014 onwards, the RoHS II Directive will apply to Medical Devices and has just been extended by the addition of a new Annex with exemptions for Medical Devices, which we have summarized for you.
I hope you find our newsletter an interesting and informative read.
Your Dr Peter Havel Senior Vice President, Medical & Health Services Global
Thorough audits for more patient safety
The EU in Brussels has been discussing the draft of a new Medical Device Regulation since 2012. In September 2013, the EU Commission anticipated some of new provisions. We talked with Hans-Heiner Junker, TÜV SÜD Product Service, about the forthcoming changes in the approval and postmarket surveillance of Medical Devices. Read more
Medical Device Single Audit Program (MDSAP)
International Medical Device Regulators Forum (IMDRF) established a working group to develop a standard set of requirements for auditing organizations performing regulatory audits of Medical Device manufacturers’ quality management systems. Read more
RoHS II follows state of the art in Medical Devices
The European Environmental Protection Directive RoHS II (2011/65/EU) will also apply to Medical Devices from July 22, 2014 and 2016 respectively. The Directive restricts the use of certain hazardous substances such as lead, mercury, or toxic flame retardants in electrical and electronic equipment. Read more
Guidance on ISO 14971
In July 2013, the International Standardisation Organisation (ISO) published the guidance document ISO/TR 24971:2013. The guidance document includes additional information on some very important aspects of the ISO 14971 standard. Read more
TÜV SÜD Malaysia approved and registered as a CAB
TÜV SÜD Malaysia is now officially accredited as a Conformity Assessment Body (CAB) for Medical Device Authority in Malaysia. This qualification allows TÜV SÜD’s experts to conduct conformity assessments on quality management systems for Medical Devices. Read more
INMETRO accreditation for TÜV SÜD do Brazil
TÜV SÜD do Brazil was recently granted accreditation by INMETRO and can act as an INMETRO Certification Body. Manufacturers that plan to place their Medical Devices on the Brazilian market can now commission us to assess and certify their electrical medical equipment. Read more