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Establishing a regulatory strategy early in the development process helps ensure the success of your project, anticipate applicable requirements, and optimize time to market.

In particular, we can assist you with:

• classify your product (medical device, DMDIV, or other regulated product);
• determine its risk class in accordance with the MDR or the IVDR;
• identify the applicable conformity assessment procedure;
• define the CE marking strategy;
• identify the applicable harmonized standards and guidelines;
• develop the regulatory roadmap;
• anticipate needs for clinical data, performance testing, or clinical investigations;
• Develop your marketing strategy for Europe and international markets.

Our goal is to provide you with a pragmatic strategy tailored to your operations, your target markets, and your growth constraints.

Pursuant to Article 15 of the MDR (Regulation (EU) 2017/745) and Article 15 of the IVDR (Regulation (EU) 2017/746), every manufacturer must have, either in-house or under contract, at least one person responsible for ensuring regulatory compliance—PCVRR (or PRRC, Person Responsible for Regulatory Compliance).

The PRRC ensures, at a minimum, that:

• The conformity of the devices must be properly verified in accordance with the quality management system prior to their release;
• The technical documentation and the EU Declaration of Conformity are prepared and kept up to date;
• The post-market surveillance obligations set forth in Article 10.10 are complied with;
• The reporting requirements set forth in Articles 87 through 91 (vigilance, serious incidents, safety corrective actions, trend reports) are met;
• For devices subject to a clinical investigation, the declaration provided for in Annex XV, Chapter II, Section 4.1 shall be issued.

Our consultants, who are qualified to meet the competency requirements set forth in these regulations, can serve in this capacity as an outsourced PRRC—a solution particularly well-suited for startups, small and medium-sized businesses, and micro-enterprises that do not have this resource in-house.

The phased rollout of EUDAMED strengthens the registration requirements for manufacturers, authorized representatives, and importers, as well as for medical devices and in vitro diagnostic medical devices.

Isocèle Conseil supports you in:

• the registration of economic actors;
• the creation and management of EUDAMED accounts;
• the registration of devices and UDI-DI;
• updating the stored information;
• preparing the data required for filing;
• support during changes to the European deployment schedule.

Our support helps you ensure that your administrative procedures are handled properly and that your records are in compliance.

For manufacturers based outside the European Union, Article 11 of the MDR/IVDR requires the appointment of a European authorized representative before any product is placed on the market in the EU.

The agent’s main obligations:

• Verify that the EU Declaration of Conformity, technical documentation, and any applicable certificate are available, and retain copies of them;
• Register the manufacturer and devices in EUDAMED, and verify the assignment of IUDs;
• Cooperate with the relevant authorities and respond to their requests for samples or information;
• Forward complaints and incident reports to the manufacturer, and communicate safety corrective actions;
• Ensure that there is always a person designated to monitor compliance with regulations (PRRC);
• Terminate the mandate and notify the competent authority and the notified body if the manufacturer fails to fulfill its obligations.

Isocèle Conseil provides this European Authorized Representative service, acting as the point of contact with the relevant authorities and notified bodies, verifying the compliance of the technical documentation and the declaration of conformity, and monitoring post-market vigilance and surveillance obligations.

Yes, when the conditions set forth in the MDR or the IVDR are met.

For micro and small businesses, outsourcing is the organizational model provided for in the regulation. A qualified PRRC may be made available under contract, provided that it is available at all times and without interruption.

This solution enables manufacturers to meet regulatory requirements while benefiting from the expertise of consultants specializing in medical devices.

The regulation requires that the PRRC have demonstrated expertise in the field of medical devices.

This skill can be demonstrated by:

• a university degree in law, medicine, pharmacy, engineering, or another relevant scientific discipline, combined with at least one year of professional experience in regulatory affairs or quality management systems as they apply to medical devices;
• or four years of professional experience in regulatory affairs or quality management systems related to medical devices.

For manufacturers of custom-made devices, at least two years of professional experience in a relevant manufacturing field may also satisfy the requirements set forth in the regulation.

Yes. The regulations allow for the appointment of multiple PRRCs. In such cases, their respective areas of responsibility must be clearly defined in writing to ensure a clear division of duties.

If your company is based outside the European Union and wishes to place medical devices or in vitro diagnostic medical devices on the European market, then yes. Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) require the appointment of a European Authorized Representative (EC REP) before any product can be placed on the market.

The European Authorized Representative is your official representative before the relevant authorities of the European Union.

However, if your company is established in a European Union member state, you are not required to appoint a European representative.

Yes, in certain cases. When a manufacturer established outside the European Union fails to comply with its obligations under Article 10 of the MDR, the European authorized representative may be held jointly and severally liable for defective devices, under the conditions set forth in Article 11 of the Regulation.

Yes. The change of authorized representative is governed by Article 12 of the MDR. It must be the subject of a written agreement between the manufacturer, the outgoing authorized representative, and the new authorized representative. This agreement specifies, in particular, the transfer dates, the procedures for transferring documentation, and the handling of any ongoing complaints and incidents.

EUDAMED is the European database for medical devices. It centralizes information on economic operators, devices, UDIs, certificates, clinical investigations, and post-market vigilance and surveillance data.

The registration requirements apply to manufacturers, authorized representatives, importers, and producers of systems and kits. Medical devices and in vitro diagnostic medical devices must also be registered in accordance with the applicable requirements.