Medical Device Regulation (MDR)

The MDR, which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), has a transition period of three years. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements.

This long awaited text brings with it more scrutiny of technical documentation; it addresses concerns over the assessment of product safety and performance by placing stricter requirements on clinical evaluation and post-market clinical follow-up, and requiring better traceability of devices through the supply chain.

The start of this long process of change occurred on 26 September 2012, when the European Commission adopted a Proposal for a Regulation of the European Parliament and of the Council on medical devices and a Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices, which replaces the existing three Medical Device Directives.  

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BSI The Netherlands is a leading EU Notified Body; we review Technical Documentation as part of a conformity assessment to ensure that medical devices meet the necessary safety and performance requirements to allow them to be placed on the market.

The BSI team has a unique set of expertise from our product and regulatory experience that allows us to provide a rigorous review of your Technical Documentation. This gives confidence in your certification to you and your key stakeholders.

BSI offers Technical Documentation review; you will be assigned a dedicated Scheme Manager to work with you throughout your product certification journey and will remain your point of contact thereafter.