What is a Regulatory Strategy?

‘’Regulatory strategy’’ or ‘’strategy for regulatory compliance’’ is a new concept in the EU regulatory framework on medical devices introduced by the upcoming Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).

More precisely, Article 10.9 (10.8 of the IVDR) and Annex IX, Chapter I of the MDR and IVDR introduce a clear requirement of having in place a Quality Management System, including:

a) a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system;

– the strategy for regulatory compliance, including processes for identification of relevant legal requirements, qualification, classification, handling of equivalence, choice of and compliance with conformity assessment procedures,

Thus, manufacturers of all classes of medical devices shall have in place a Quality Management System (QMS) that includes a Standard Operating Procedure (SOP) documenting the compliance process on the EU market, governing aspects such as classification of devices, conformity assessment procedures and identification of applicable GSPR, management of device’ modifications, roles and responsibilities of involved actors (PRRC, E.A.R., distributors,…), etc.

The deadline for implementing the regulatory strategy is fixed at the general date of application of both Regulations. Therefore, as of 26 May 2021, all manufacturers of medical devices, including Class I, custom-made and legacy devices manufacturers shall have in place a Regulatory Strategy SOP. In-vitro diagnostic medical device manufacturer shall comply as of 26 May 2022!

Do you need further help on the necessary elements to be included in your Regulatory strategy ?

Our experts prepared dedicated tools to assist you with greater details available in our Store:

MDR Regulatory Strategy: implementation guide

IVDR Regulatory Strategy: Implementation guide


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