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MDR & IVDR – Companies must act

The EU Regulations for medical devices and in-vitro-diagnostics are casting their shadows.

During the past years, several scandals involving medical devices caused European committees to radically revise the former directives 93/42/EEC and 90/385/EEC and to adapt them to current technical standards. A so-called Medical Device Regulation (MDR) became binding this year, with a 3-year transition period.

In particular, quality and safety requirements for medical engineering companies and associated services have been intensified. Key changes concern, among other things, the conduct of clinical studies (e.g. in regards to clinical evaluation), the labeling of medical devices (UDI, among others) as well as a stricter control of manufacturers (increased number of audits or conducting of unannounced audits).

Regarding In-vitro-diagnostic devices, Directive 98/79/ EC has also been revised and is available as a draft. The introduction of the In-Vitro-Diagnostic Regulation (IVDR) is also planned for 2017 and will become binding with a 5-year transition period. Both European regulations are legislative acts and set a high safety standard for patients and users. The goal is the assurance of a homogenous and well-functioning EU internal market, taking into consideration the infrastructure of smaller and medium-sized medical device manufacturers.

MDSS GmbH will analyse  with you your existing documentation and demonstrate  to what extent you must become active in order to fulfil the new requirements.
Based on a gap analysis we will identify the discrepancies between the actual state within your organization and the target criteria of the legal requirements of the MDR or IVDR - while maintaining your present company policy.

We will be happy to guide you though these times of regulatory challenge. Please do not hesitate to contact us!

Read the new EU Regulations here [pdf]: