From 5 May 2017

On Friday 5 May 2017 the new EU regulations MDR (2017/745) and IVDR (2017/746) were published in the Official Journal of the European Union and are mandatory from 26 May 2017 for all medical technology companies that want to market their medical devices and medicinal products in the European Union.

It is advisable for both large and small medical technology companies to read the final texts and to start making the preparations for the transition processes as soon as possible.


With the implementation the directives for medical devices (93/42/EEC) and active implantable medical devices (90/385/EEC) will be merged and superseded by the Medical Device Regulation (MDR). Following a transition period of three years, these directives will no longer be valid. From 25 May 2020 the MDR alone will be effective. The directive for in-vitro diagnostic medical devices (98/79/EC) will no longer be valid after a transition period of five years. From 25 May 2022 the IVDR alone will be effective.

Nevertheless, depending on the route selected it is also possible to launch a medical device up to 26 May 2024 in accordance with the above directive onto the European market and thus in accordance with the Medical Devices Act in Germany and the national legislation in the EU and EEA. This option is a special scenario, however. Most products are expected to be recertified no later than five years from 26 May 2017.

Other transition deadlines can be found in Article 120 (MDR) and Article 110 (IVDR). It is also extremely important to know that once the regulations become valid there will be an adequate number of notified bodies in accordance with the new provisions so that the current market bottlenecks can be avoided.

In the opinion of the Medical Technology Association BV-MED, the transition period for the new EU medical device directive is, however, somewhat tight in light of the comprehensive new requirements for the notified bodies, the clinical evaluation of medical devices, due to the new plan and reporting obligations and the new Eudamed/UDI database system. For the time being, the national medical devices acts and corresponding EU directives MDD, AIMDD and IVDD still apply. It is advisable, however, for manufacturers to prepare themselves now for the new or refined requirements and to start with the implementation this year. The national health ministries have the task of adapting the national Medical Devices Act (MPG) and its regulations to the new law because identical or contradictory national law is not permitted.


It is recommended to carry out a comprehensive analysis of the status quo in terms of

• classification of products
• period of validity of certificates
• technical documentation
• existing instruments for product surveillance


throughout the entire product life cycle. This can be used to best identify which additional efforts must be made to bring companies into harmony with the MDR and IVDR and to be able to obtain CE certification in accordance with the new MDR / IVDR.


Small and medium-sized companies in particular have to find ways of satisfying the considerably higher requirements for quality and risk management, technical documentation and the preparation of clinical data or the clinical evaluation while also being able to meet the requirements for UDI labelling and increased reporting obligations. The MDR requires periodic, in some cases annual, updates to post-market surveillance plans/reports, post-market clinical follow-up studies, periodic safety update reports and summaries of safety and clinical performance.