The EU’s Medical Device Regulation (MDR) came into force on 25 May 2017 and will start fully applying on 26 May 2021 (it has been postponed by one year due to Covid-19 pandemic). MDR will replace current Medical Device Directive 93/42/EEC (MDD) and the Directive on active implantable medical devices 90/385/EEC (AIMDD). The new regulation is meant to increase reliability, safety and performance of the medical devices.
For many medical devices currently placed on the market, additional clinical data will have to be generated to enable CE-marking under the MDR. This process takes time and due to Covid-19 pandemic, many clinical investigations have to be postponed. Are you sure that as a manufacturer, you will be in possession of sufficient clinical evidence by the time the current CE-certificate of your medical devices expire?
The MDR has introduced some significant changes and revolutionized the MedTech world. All medical devices that have been certified under the MDD or AIMDD, must now be re-certified according to the new requirements set by the MDR. “Grandfathering” cannot be arranged!
Manufacturers will have to make sure that they are familiar with the new MDR’s classification rules and update their technical documentation. It might mean that your medical device will have a completely different class and so it will require a different approach from your side.
For class III and implantable medical devices, higher clinical requirements have been introduced. Just to give you a general overview of the current situation... most medical devices that you can find on the market have been certified with few clinical data. Often, Post Market Clinical Follow-up was only based on the update of the bibliographical clinical evaluation obtained during the pre-market phase. Currently, in order to re-certify many medical devices, the Manufacturers will have to conduct a proper pre-market clinical investigation to demonstrate device’s claims in terms of safety and performance. In order to maintain medical devices’ certifications, Manufacturers might be obliged to have a plan of Post-Market Clinical Follow-up studies which will assure that the safety and performance claims are confirmed.
Another important change is, that the Manufacturer will need to identify a person responsible for regulatory compliance, and there will be more surveillance and control by Notified Bodies.
All these changes make it more complicated to develop a new medical device. For already existing medical devices, it will be more complicated to be MDR complaint for re-certification purpose.
As a Manufacturer you will need at least to:
- Identify a person responsible for regulatory compliance (PRRC)
- Classify properly your medical device
- Verify if medical device’s safety and performance requirements are met
- Verify if new requirements for clinical evidence are met
- Make sure that all your business partners (economic operators) are MDR compliant
- Comply with Vigilance requirements (reporting timelines, PMS-Report or Periodic Safety Update Report (PSUR) are drafted).
Does it seem overwhelming and complicated? MTA is here to support you all the way!