MDR/IVDR Voyage Specialists
The EU medical device regulatory scheme known as MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) is either in force or is very close to completing transition.
The MDR and IVDR require ALL currently CE Marked medical devices to be re-assessed for product classification changes, changes to the requirements for CE Marking, and changes as to which Notified Bodies are designated for the product and QMS reassessments. All new medical devices as well as those with design and or labeling changes must go through assessment under MDR/IVDR. In addition, many ‘devices’ previously not under the regulation (ex. photooptical aesthetic beauty) now have requirements. The most drastic of the CE Marking changes are in store for IVDs. Whilst under the previous IVDD regulation, 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 are far fewer IVDR Notified Bodies, so it’s crucial that manufacturers ‘plot a course’ soon.
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 fill out the webform below and tell us which of the above services and timeframe you are interested in.
