Affixing a CE mark to a medical device is one of the legal requirements of placing a device on the market in the European Union. In doing so, it is the medical device manufacturer’s claim that their product meets the essential requirements of all relevant European Medical Device Directives. This “CE marking” was first implemented in the 1990’s, and was based on the Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD). Details on the requirements of CE marking can be found on MAP Online.
In order to update these Directives two new regulations the Medical Devices Regulation (2017/745/EU) and the In-Vitro Diagnostic Medical Devices Regulation (2017/746/EU) were introduced in May 2017 and will come into force after the 3 year transitional period for medical devices (26th May 2020) and 5 years (26th May 2022) for in vitro diagnostic medical devices.
The Medical Devices Regulation (2017/745/EU) means Notified Bodies will be required to meet more stringent criteria, particularly in terms of clinical competence. They will also now have the duty to perform unannounced random audits on manufacturing sites at least every five years. For in-vitro diagnostic medical devices Notified Bodies will also be required to meet more stringent criteria, particularly in terms of scientific and technical evaluation competence. Notified Bodies can apply to be designated under the new regulations from 26 November 2017, a process which might take 12 months or more. Some Notified Bodies may not continue their operations, leaving manufacturers without a certification partner. In particular after the UK’s withdrawal date from the EU, 29 March 2019, UK Notified Bodies will lose their status as EU Notified Bodies. Further details on upcoming changes for the UK are available on MAP Online.
As such, MAP recommends manufacturers verify whether their Notified Body will be designated under the new Regulation and whether the scope of its designation covers all their products. They should liaise with the Notified Bodies to plan the timing of certification for the product portfolio, taking into account the availability of the Notified Body, the need for additional data on devices and the transitional provisions in the new Regulation. Manufacturers should also consider preparing for more frequent unannounced checks in the future.
For more detailed information, companies should consult the roadmaps published by the EU Commission and the MHRA, which list the actions companies will need to take and suggests strategies to implement those actions. The database of Notified Bodies (NANDO) can be found here. To read the information published by the European Commission on the MDR, click here. To read the legislation in full, click here.