Report 1

Medical device manufacturers will soon be confronted with major changes to the EU’s regulatory framework that governs market access to the European Union (EU).

The Medical Device Regulation (MDR) came into force on May 25th 2017. Manufacturers of currently approved medical devices will have a transition time of three years (until May 26th 2020) to meet the requirements of the MDR. For some manufacturers the new MDR provides an additional time after the date of application, allowing them to place new products for maximum of four more years on the market. Additional requirements will apply for this extended transition period. Click here to access the published MDR on the Official Journal of the European Union.

The MDR will replace will replace the existing current Directives:

• Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990);
• Council Directive 93/42/EEC on Medical Devices (MDD) (1993); and
• Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD) (1998).

The MDR differs in several important ways from the EU’s current Directives for medical devices, including active implantables. Changes in the regulations include:

• expansion of the scope of products covered; and
• more rigorous requirements for clinical evaluation including:
  • changes to clinical investigations;
  • mandatory unique device identification (UDI) mechanisms; and
  • increased post-market oversight by EU Notified Bodies.

Under the MDR, all currently approved devices must be recertified in accordance with the new requirements. Manufacturers with currently approved devices will have three years to demonstrate compliance with the MDR’s new requirements. However, exemptions are currently being negotiated on a case-by case basis.

The new regulations will provide:

• stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level;
• reinforcement of the criteria for designation and processes for oversight of Notified Bodies;
• inclusion of certain aesthetic devices which present the same characteristics and risk profile as analogous medical devices under the scope of these Regulations;
• introduction of a new risk classification system for in vitro diagnostic medical devices in line with international guidance;
• improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification;
• introduction of an “implant card” containing information about implanted medical devices for a patient;
• reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorisation of multi-center clinical investigations;
• strengthening of post-market surveillance requirements for manufacturers; and
• improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance.

The major impact of the MDR will be felt in the following areas:

• The definition of medical devices and active implantable medical devices covered under the MDR is expected to be significantly expanded to include devices that may not have a medical intended purpose and devices designed for the purpose of “prediction” of a disease or other health condition such as:
  • Contact lenses or other articles intended to be introduced into the eye;
  • Products intended to be totally or partially introduced into the human body through surgically invasive means to modify anatomy or fixation of body parts;
  • Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty;
  • High intensity electromagnetic radiation equipment intended for use on the human body, such as lasers and intense pulse light equipment for skin resurfacing, tattoo or hair removal or other skin treatment; and
  • Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields.
• The MDR will require device manufacturers to review the updated classification rules and update their technical documentation accordingly by considering the fact that Class 111 and implantable devices will have higher clinical requirements and a regular scrutiny process.
• It is expected that device manufacturers will also be required to collect and retain post-market clinical data as part of the ongoing assessment of potential safety risks. These changes will result in a dramatic increase in the time and resources needed by manufacturers to conduct the required studies and to maintain post-market documentation.
• Manufacturers will need to conduct clinical investigations in case they do not have sufficient clinical evidence to support the claims done on both safety and performance of a dedicated device.
• Manufacturers will need to re-prepare their clinical evaluations of Class IIa and Class IIb medical devices by considering the new wording of the regulation on when an equivalence approach and under which circumstances it is possible to justify not conducting a clinical investigation.
• Device manufacturers will be required to identify at least one person, a “Qualified Person”, within their organisation who is ultimately responsible for all aspects of compliance with the requirements of the new MDR. The organisation must document the specific qualifications of this individual relative to the required tasks. Further, qualifications of responsible persons will be subject to review by Notified Bodies to ensure requisite knowledge and skill.
• The MDR mandates the use of Unique Device Identification (UDI) mechanisms. This requirement is expected to increase the ability of manufacturers and authorities to trace specific devices through the supply chain, and to facilitate the prompt and efficient recall of medical devices that have been found to present a safety risk. To support this effort, the European Databank on Medical Devices (Eudamed) is expected to be expanded to provide more efficient access to information on approved medical devices.
• The MDR will grant Notified Bodies increased post-market surveillance authority. Unannounced audits, along with product sample checks and product testing will strengthen the EU’s enforcement regime and help to reduce risks from unsafe devices. Annual safety and performance reporting by device manufacturers will also be required in many cases.
• The MDR will give the EU Commission or expert panels the authority to publish Common Specifications. These Common Specifications would exist in parallel to the Harmonised Standards and will be seen as State of the Art, and would be considered as part of the evaluation process by Notified Bodies.

The main implications for business planning are likely to be:

• Compliance timelines and planning;
• Re-classification or up-classification of products;
• Update/review/revision device Technical files;
• Number of Notified Bodies available;
• Increase Vigilance and Post market surveillance monitoring, reporting requirements;
• Establish UDI system and registration of products and transparency of information in EUDAMED;
• Increase in staff and training;
• Increase in Distributors, AR and Importer Responsibilities and Requirements; and
• Review and update data for Clinical Evidence and review of PMS clinical data – lengthy and costly clinical trials.

• 7/1/2017 – early 2019: Notified Bodies re-designation process.
• 26/11/2017: Conformity assessment bodies may apply for designation as notified bodies under Regulations (EU) 2017/745 and 2017/746.
• Early 2019: Full applications of the MDR will be in place, no longer possible to issue CE mark under the MDD.
• 2/2/2020: All CE marks will be required to be issued under the MDR.

CE Certificates issues prior to the FINAL implementation of MDR in 2/2/2020 will have expiry date of 5 years validity.

CE Certificates issued before implementation of the new regulations will automatically expire four years after the new regulations came into force.