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Services for Active Medical Devices


TÜV Rheinland

So much of today’s medical landscape, including diagnostics and all levels of treatment, rely on active medical devices. Active MDD cover all devices requiring a power source other than the body itself or gravity. Lives and health depend on the safe and accurate functioning of such instruments, and your company is dedicated to providing doctors, hospitals and paramedics with life-saving tools of the highest standard. In addition to maintaining a high level of performance internally, this means complying with external directives and regulations set forth by national and international authorities. Well-versed in the intricacies of medical device compliance worldwide, our experts offer services designed to meet your needs. Our laboratories, located across the globe, are among the most sophisticated in the world, and we provide the expertise to match.

TÜV Rheinland LGA Products GmbH is a Notified Body for the EU Medical Devices Regulation (MDR) 2017/745

Medical Device Regulation (MDR) 2017/745

The European Medical Devices Regulation 2017/745 (MDR) came into force on May 25, 2017 and will replace the two Directives 93/42/EEC (MDD) and 90/385 EEC (AIMDD) by May 26, 2020.
Starting immediately, you may submit your application for MDR certification.

Unannounced audits

Unannounced audits

Commission Recommendation of 24th September 2013 on the audits and assessments performed by notified bodies in the field of medical devices (2013/473/EU) was published on 24 September 2014 and entered into legal force on 25 September 2013 by publication in the Official Journal of the European Communities.

New Regulations for Medical Products

pdf New IVDR 1 MB Download
pdf New MDR 1 MB Download
pdf FAQ on the new European Medical Device Regulation (MDR) 362 KB Download
pdf MDR / IVDR declaration of interest 46 KB Download

Market Access Services

Unlock your international success with our Market Access Services. To ensure a smooth and fast market access, we support you with all necessary certifications, inspections and regulatory researches.

Activate your access to new markets now.

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Contact

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