Prepared for the New MD & IVD Regulations
We imagine all manufacturers, and in fact almost anyone involved with medical devices, will now be aware of the arrival of the big regulatory changes in Europe.
The original EU Medical Device Directive (MDD), IVD Directive (IVDD) and Active Implantable Medical Device Directive (AIMDD) have been deemed as being out of date and no longer able to reflect the changes to our industry and the new technologies being used.
The original “Directives” were created in the early 90’s and in fact Advena personnel were closely involved with their development and the preparation of the associated standards that are so familiar to Advena and all device manufacturers.
But now we have new requirements that have been cast into EU legal regulation to assure a concentration on product safety and accordingly manufacturers now have to take more seriously their responsibility for their design, manufacture, inspection, product performance etc. of medical devices.
The final text of the new European Medical Devices Regulation (MDR) was published in the Official Journal of the European Union and entered into force on 25th May 2017 marking the start of the transition period for manufacturers selling medical devices into Europe.
The MDR, which replaces both the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), has a transition period of three years. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements.
This brings with it more scrutiny of technical documentation and addresses the EU authority’s recent concerns over the assessment of product safety and performance by, amongst other things, placing stricter requirements on clinical evaluation and post-market clinical follow-up and requires manufacturers to have better traceability of devices through the supply chain up to the end user.
The new In-Vitro Diagnostic Device Regulation (IVDR) (EU) entered into force on the same day, 25 May 2017, and replaces the In-Vitro Diagnostic Device Directive 98/79/EC. This new Regulation imposes new and challenging requirements upon manufacturers who must comply by the end of the 5-year transition period. Most particularly manufacturers are expected to update all technical documentation related to their IVDs and many devices will be moved to higher classifications and require third party (Notified Body) certification.
Until the end of the respective transition period manufacturers may continue to apply the CE mark in accordance with the original Directives. Any new devices placed on the market after the end of a transition period must conform to the new regulations.
So be prepared but on the positive side it should be remembered that ALL manufacturers and suppliers of medical devices into the EU will have to comply and although the cost of compliance will increase it will not make any difference to business competitiveness on the level playing field.
Advena assure all our clients that after 20 years’ experience in keeping up-to-date with a progression of regulatory changes we are continuing to be a leading advisor on any new medical device or cosmetic product regulations. Despite political turmoil in Europe we will continue to be a prominent English-speaking international medical device and cosmetics consultancy, uniquely based in the UK and Malta, to assist clients in aspects of regulation, quality systems, and device registrations.