MDR odłożone o rok – jak zaplanować strategię działania?

MDR postponed for a year – how to plan the implementation stategy?

Regulation of the European Commission No. 745/2017 (MDR) significantly changed the requirements set out in the current Directives 93/42 / EEC and 90/985 / EEC was prepared for many years. After long expectations, in 2012 the first proposal for a Regulation was presented, which is much more restrictive than the applicable law. Therefore, many significant comments and proposals for the Regulation were made, so it lasted up to 5 years to publish the final version. Therefore it is not surprising, that companies and organizations in the medical industry have been worried by the fact about short implementation period of the new law.

In the context of the global crisis caused by the COVID-19 pandemic, the European Commission has decided to postpone the date of application of this Regulation by one year. On April 24, Member States accepted the proposed amendment, which resulted in the publication of the amending regulation in the Official Journal of the European Union. Since then, the entire medical industry has been able to focus on priority activities related to the fight against COVID-19, but also on flexible management and adaptation of the company’s operations to changed working environment.

Medical Device regulation in 2021

As a result of our cooperation with many European companies in the medical industry, we have a clear overview on the current situation inside the organizations. Our review shows that currently all funds and budget plans are staff-oriented and focused to maintain market position. The effects of a pandemic can significantly change the approach to process management and strategies to deal with the restrictive requirements of MDR.

Find below three strategies that will bring your company one step closer to the implementation of the MDR.

  1. Use time proactively. Don’t make the same mistake you did a year ago – just because you have an extra year to prepare doesn’t mean that you only need a few weeks to implement all the rules. Analyze the necessary changes, plan activities, set approximate dates and involve responsible people. Do not count on the fact that after the pandemic your company will have enough time to implement it.
  2. Establish rules in relations with other business contrahents in the supply chain: with an authorized representative, distributor or importer for non-EU manufacturers. The Medical Device Regulation (MDR) introduces a number of provisions regarding the relationship between all participants in the supply chain, up to the end user. Organize working activities so that each obligation under the Regulation can be performed in a systematic way to provide an evidence of compliance with the requirement and without unnecessary repetition of activities. Introduce common processes of the quality system, common tools for monitoring them and sign the necessary cooperation agreements regulating the scope of responsibilities.
  3. Begin the process of implementing or optimizing the quality management system (QMS). MDR defines specific requirements for medical device manufacturers regarding the establishment, implementation and management of the QMS. Remember that the ISO 13485 standard covers compliance with legal requirements, which are referenced 37 times in the standard. To sum up, you will get two benefits: effective MDR implementation will ensure your company has a well-functioning quality management system, and on the other hand the implemented QMS will ensure compliance with MDR.

MDR Regulator is ready to help

MDR Regulator‘s consultants are ready to cooperate with your company regarding the new requirements of the Medical Device Regulation. We offer support in: obtaining the required documents for the implementation of new products before entering the MDR, preparing the MDR/IVDR implementation strategy, creating the necessary technical documentation in accordance with the new requirements, contact with notified bodies and competent authorities in the field of conformity assessment and notification procedures. Together, we will define the scope of activities and choose the best solution. If you would like to cooperate, please contact us.