BÖNNIGHEIM (ivs) Manufacturers of medical devices are about to experience a sweeping change in regulations. The new EU Medical Device Regulation (MDR) is coming into effect, replacing the Medical Devices Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC). The transition period ends on 26 May 2021. With its accredited testing laboratories for medical devices, Hohenstein is ideally geared to testing the efficiency and safety of medical devices in accordance with the new regulation. Many of its testing methods already lay a foundation for documentation processes as part of conformity assessments.
What will change under the MDR?
The new MDR is primarily aimed at manufacturers of medical devices, but its comprehensive requirements also affect the users and distributors of medical devices, such as specialists in medical supplies and pharmacies. Among the biggest changes will be new reporting and documentation requirements. So-called incident reporting previously only affected incidents of a serious nature, or malfunctions that could cause life-threatening injuries to patients or pose a risk to public health. In future, reports will have to includeall undesirable effects on patients, as well as all kinds of medical device defects and malfunctions. For example, this includes faulty instructions. The new MDR also focuses attention again on stricter requirements regarding the reprocessing of medical devices.
Hohenstein offers solutions
The new MDR adopts a life-cycle approach to medical device safety and this will be underpinned by clinical data and new requirements such as transparency and traceability. Among other things, this will require manufacturers to be able to point to quality management processes and risk management systems based on specific products. They must also provide evidence of comprehensive clinical evaluations. As an accredited test laboratory for medical devices, Hohenstein supports the sellers and distributors of medical devices by providing rapid and professional evidence of testing for use in technical documentation, risk evaluations and clinical assessments. Naturally, other stakeholders in the medical device supply chain can also make use of Hohenstein testing to safeguard conformity with MDR requirements. On request, as a provider of testing services Hohenstein also conducts experiments and tests over and beyond common standards – for example if medical devices offer health benefits and thus require corresponding declarations.
Accredited and well networked
One of Hohenstein’s main specialities is inspecting Class I medical products. For example it has been accredited by the German National Accreditation Body (DAkkS) for testing medical masks in keeping with standard DIN EN 14683. In addition, Hohenstein laboratories analyse the performance and effectiveness of surgical gowns in accordance with DIN EN 13795, as well as compression stockings under RAL-GZ 387. To ascertain biocompatibility, Hohenstein conducts testing according to the DIN EN ISO 10993 series of standards, including cytotoxicity testing under DIN EN ISO 10993-5 and chemical characterisation under DIN EN ISO 10993-18. The experts at Hohenstein are extremely well connected in the industry. By forging a partnership with seleon GmbH, which is based in Heilbronn and considered a leading international provider of medical technology services, it is in an ideal position to support clients in all matters relating to regulatory affairs. In addition, Hohenstein has been commissioned by state-owned company BIOPRO Baden-Württemberg to act as a moderator in forming consortia of medical technology companies. The idea of these consortia is to develop basic documents for individual medical device groups as part of the MDR Rapid Response Programme. Documents for two product groups – an orthotic seat shell and an orthopaedic custom shoe – can now be ordered for a fee by writing to email@example.com. Work in the Medical Face Mask product group has reached the implementation phase. The basic document for clinical evaluations of medical face masks is expected to be available soon.
For further information on Hohenstein testing of medical devices, see here.
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Details on the new European Medical Device Regulation can be found here.
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Headquartered in Bönnigheim, Germany, Hohenstein has been providing accredited and independent services such as testing, certification, research and the development of textile products and training for 75 years. It currently employs around 1000 employees at subsidiaries and laboratories around the world. Product labels such as the Hohenstein Quality Label or the UV STANDARD 801 provide manufacturers and retailers with important support in their marketing. As a founding member of the OEKO-TEX® label, Hohenstein is also one its most important testing laboratories.