Medical Devices

Whether a medical device requires a Notified Body (in the case of Class I sterile/measuring/resusable, or IIa, IIb, III) in order to obtain the CE Marking or is permitted to self-declare (Class I non-sterile, non-measuring), non-EU based manufacturers are legally obligated to appoint an Authorised Representative in order for their products to legally circulate within the EU Market.

Under the Medical Device Regulation, the Authorized Representative must be permanently and continuously available, qualified, and possess the necessary expertise of the regulatory requirements for medical devices in the EU. More specifically, your Authorised Representative should have specifically identified a Person Responsible for Regulatory Compliance (PRRC) within their organization. A distributor, importer, or EU Address without a qualified professional will no longer do.

Formal qualification criteria for E.A.R.’s PRRC – MDR Article 15 (6):

1. University degree (documented by Diploma/Certificate) in law, medicine, pharmacy, engineering or another relevant discipline + at least one year of professional experience in regulatory affairs or in QMS relating to medical devices, or
2. four years of professional experience in regulatory affairs / in quality management systems relating to medical devices.

The currently applicable Medical Device Directive has been repealed by the Medical Device Regulation (MDR) on the 26th of May 2021. In-Vitro Diagnostics devices are regulated by the In-Vitro Diagnostic Devices Directive. This Directive has been repealed by the In-Vitro Diagnostic Devices Regulation (IVDR) on the 26^th of May 2022. One of the requirements set out in the MDR and IVDR is that the device needs to be registered to the European database on medical devices – EUDAMED.

EUDAMED consists of 6 modules, which are not yet fully functional:

1. Actors registration
2. UDI/Devices registration
3. Notified Bodies and Certificates
4. Clinical Investigations and performance studies
5. Vigilance and post-market surveillance
6. Market Surveillance

From December 2020, EUDAMED Actor registration is possible. From September 2021, second and third module of EUDAMED became active (UDI/device registration & module on Certificates and Notified Bodies). Other modules (on vigilance, clinical investigations, etc.) will be displayed later on, as soon as they are functional. Full functionality of EUDAMED is envisaged for May 2023. Until EUDAMED is functional, medical devices are still to be notified to the relevant EU Member States’ Competent Authority.

Do not forget that the UK has officially left the EU! EUDAMED Registration is not relevant for the devices that are to be placed on the UK market, however there is a mandatory registration to the UK Competent Authority MHRA. Obelis UK, as UK Responsible Person will gladly register your medical devices on the UK market!

The Medical Devices Regulation (EU) 2017/745 has introduced some major innovations to the European regulatory legislative framework. Among the various areas disciplined by the Regulation, MDR has brought about some innovation in respect to the players of the regulatory field, namely on the figure of the Authorised Representative (AR) and it clearly outlined the role of the Person Responsible for Regulatory Compliance.

According to the MDR, the Authorized Representative plays a pivotal role in ensuring the compliance of the devices and in serving as extra-EU manufacturers’ contact person established in the Union.

The AR is jointly responsible for defective products and must terminate the contract with the manufacturer in case the manufacturer has not complied or in case it acts in a way that conflicts with the obligations laid down in Article 10. Consequently, the AR is liable for defective products when the manufacturer has not complied with its obligations.

Differently from what laid down by the Medical Devices Directive 93/42/EEC, the MDR clearly states that the AR is mandatory for non-EU manufacturers only; and solely on the basis of a received and accepted mandate to act on behalf of the manufacturer.

MDR furthermore clearly outlines the core of the role of the AR and its obligations and the minimum qualifications that this figure must hold. The minimum role of the AR encompasses a series of obligations, such as:

• To verify that the technical file and other essential documents have been drawn-up, and that the manufacturer has complied with his registration obligations;
• To provide the competent authority with all the information and documentation necessary to demonstrate the conformity of a device;
• To forward to the manufacturer any request by its competent authority for device sample;
• To cooperate with the competent authorities on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices;
• To immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.

As per the minimum qualifications, the Authorized representatives shall have permanently and continuously at their disposal at least one Person Responsible for Regulatory Compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union. The requisite expertise shall be demonstrated by either of the following qualifications:

• A diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices, OR
• Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

MDR has outlined the figure of the Person Responsible for Regulatory Compliance (PRRC) and cleared out its role in relation to the AR and to the manufacturer. Each Authorized Representative has to have its own PRRC, whose role is to ensure that the:

• “Minimum mandate” between the manufacturer and the AR fulfils all the requirements of the regulations and it is signed by both parties;
• AR correctly performs the tasks as defined in the regulations’ articles 11.,
• Responsibilities as laid down in article 15.3 and in the mandate are fulfilled by the AR.

Each Authorized Representative has to have at least one PRRC, that should be located in the EU. Manufacturers of medical devices must have a PRRC as well, provided that the PRRC’s roles for the AR and for the Manufacturer cannot overlap for the sake of keeping an additional level of scrutiny entrusted to the AR as envisaged by the Regulations.

Notified Bodies play a key role in supporting manufacturers to place only safe and compliant medical devices on the EU Market. They are controlling the manufacturers by carrying out conformity assessment procedures and grant conformity certificates to medical devices. There are certain expectations that a Notified Body must meet before being officially accredited by the EU Commission. A key aspect of their role is to audit the quality management system of the manufacturer and review the technical documentation of devices in class Is/Im/Ir, IIa, IIb and III.

Notified bodies will issue before issuing CE Certificates and/or Technical Documentation Assessment or Type Examination Certificates depending on the class of the device. Manufacturers can consult the European Commission´s complete directory of Notified Bodies (available on the NANDO website).

Scrutiny by Competent Authorities over Notified Bodies has been reinforced with the MDR, the number of existing Notified Bodies have dramatically decreased throughout the years, therefore selecting a Notified Body device can be a complex process, it is also advised that an external expert supports this critical decision.

Notified bodies shall conduct surveillance on site audit at least on an annual basis as well as unannounced audit of manufacturer and where applicable subcontractors and suppliers.

As of May 2021, as an importer or distributor of medical devices, you have the legal obligation to ensure that the devices you are making available on the EU market comply with the MDR.

By importing or distributing medical devices from manufacturers based outside the European Union, you must add your company details, review and store labels, instructions for use, CE Certificate, declaration of conformity, UDI codes, keep a register of complaints, of non-conforming devices and of recalls and withdrawals and more.

As Authorized Representative for the manufacturer, Obelis will:

• Conduct a full regulatory review of the manufacturer quality management system and technical documentation of his medical devices.
• Provide a vigilance contact point.
• Store the product technical documentation for over 10 to 15 years.
• Verify EUDAMED device registration.
• Validate the manufacturer’s registrations on the EUDAMED portal.
• Work directly with the manufacturer at no costs to you as importer.