The CRO Group > Services

MDR/IVDR Voyage Specialists

The current medical device regulatory scheme in the EU, known as AIMD, MDD, and IVDD Directives,  is significantly changing with all manufacturers required to meet the new requirements by May 2020 (AIMD/MDD) and May 2022 (IVDD).

These changes will result in ALL currently CE Marked medical devices needing to be re-assessed, changes to product classifications, changes to the requirements for CE Marking, and changes to the number and scope of operation of the Notified Bodies.  All new medical devices which require Notified Body assessment and or approval can be classified and assessed as early as 2019 under the new scheme (as soon as Notified Bodies receive authorization from Competent Authorities.  By 2020/2022, assessment under the new MDR/IVDR will be required.  In addition, many ‘devices’ previously not under the regulation (ex. photooptical aesthetic beauty) now have requirements. The most drastic of the product changes are in store for IVDs. Under the IVDD, approximately 80% of the products had no Notified Body involvement. That ‘ship has turned around’ and under the IVDR, 80% will require Notified Body assessment, and there will be far fewer IVDR Notified Bodies, so it’s crucial that manufacturers ‘plot a course’ soon.  Adding another wrinkle may depend on how the Brexit plan plays out, particularly if the UK Authorised Representative or Notified Body does not open an office in the EU.

CRO Group is well prepared to organize your ‘voyage’ under the MDR and or IVDR, and help prepare you for the ‘stormy seas ahead.’

The first step in our process is a Training in MDR/IVDR requirements.  The training is available today via web or on-site depending on company size and logistics.

From the training, the next step is to perform a gap analysis for current CE Marked as well as future products under development, as well as the Quality Management System.  We can work with your team for the gap analysis, act as a qualified team member for certain essential requirements (ex. electrical safety, EMC, software), or do the whole thing if you’re resource stressed and stretched.

Following the gap analysis, CRO Group can assist in developing the plan (which generally takes the form of a Quality Plan) to meet the existing and new product and QMS requirement deltas, serve as the Project Manager, as well as serve in any team role (technical documentation, design V&V, clinical development, SOP writing and revision, etc.)  Also as part of the Plan, CRO Group works with the reduced number of Notified Bodies who will be continuing under the MDR and IVDR, and can assist in your transition plan. A number of leading regulatory experts as well as trade groups and other related organisations have already ‘rang the alarm bell’ that time is fleeting, and manufacturers and Notified Bodies getting everything done in time may not be realistic.  Nevertheless, CRO Group is committed to join your team, and keep your ‘voyage on a steady course.’

To get ‘underway’, simply click on the link and in the webform tell us which of the above services and timeframe you are interested in.