The Medical Device Regulatory & Quality Experts.

"A Quality Management System (QMS) is a framework comprising processes, controls, and policies that guide specific operations within an organization's defined scope. Under Article 10 of the EU Medical Device Regulation 2017/745 (MDR) and the EU IVD Regulation 2017/746 (IVDR), it is mandatory for manufacturers to establish and maintain a QMS, applicable to all risk classifications. However, manufacturers of only Class I medical devices or Class A IVDs are exempt from having their QMS evaluated by an external Notified Body (NB).

EN ISO 13485:2016 is the industry benchmark for implementing a QMS in medical devices. The recent A11:2021 amendment to this standard, including Annexes ZA and ZB, aligns the QMS requirements from the EU MDR and IVDR with ISO 13485:2016's provisions. Although lower-risk classifications do not mandate further evaluation, adherence to this standard remains a valuable practice."

"Focusedmedical's Import Assist provides a solution for organizations introducing medical devices into the EU market by enabling them to outsource specific responsibilities outlined in EU Regulations 2017/745 and 2017/746. We recognize that managing the extensive obligations and requirements faced by importers can be challenging.

Leveraging our expertise in compiling technical documentation for the EU, Focusedmedical is well-equipped to review and confirm that the information and documentation received from the legal manufacturer aligns with EU legislation and industry best practices."

"We will thoroughly verify all essential technical documentation. This process primarily includes the examination and validation of the EU Declaration of Conformity, ensuring it aligns with EU standards. The Declaration of Conformity must contain several crucial elements that should be clearly indicated in the document.

Additionally, if your organization requests supplementary documents, such as a Device Description or Classification Rationale document, we will also review these to confirm their accuracy and completeness."

"An EU Authorized Representative (AR), also known as an EC-REP or a medical devices EU Representative, is an individual or organization based within the European Union (EU) designated by a non-EU manufacturer to represent them for specific product categories. While larger companies may choose to appoint an EU-based subsidiary as their AR, numerous manufacturers prefer to engage third-party services for this role.

This representative is tasked with ensuring the manufacturer's compliance with all pertinent EU regulations, particularly Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in-vitro diagnostics (IVDR).

The obligation for medical device manufacturers to appoint an Authorized Representative is not a new concept; it was also mandated under the previous Medical Device Directives 93/42/EEC, 90/385/EEC, and 98/79/EC. However, the introduction of these new Regulations has expanded the legal responsibilities of the AR, intensifying the regulatory scrutiny imposed on medical device companies."

"Focusedmedical offers a comprehensive suite of training courses, available both online and onsite, tailored to the intricacies of the EU Medical Device Regulation 2017/745 (MDR) and EU IVD Regulation 2017/746 (IVDR). Our training portfolio includes highly sought-after courses such as:

1. Post-Market Surveillance Activities and Post-Market Clinical Follow-up: Dive into the critical aspects of ongoing product monitoring and clinical evaluation post-launch.

2. Obligations of Importers and Distributors (Articles 13 & 14): Understand the key responsibilities and legal requirements for importers and distributors under the MDR and IVDR.

3. Person Responsible for Regulatory Compliance (PRRC) (Article 15): Gain insights into the role and duties of PRRCs in ensuring regulatory adherence.

4. Directive-Regulation Transition: Navigate the transition from previous directives to the current regulations seamlessly.

Located in Malta, we also specialize in training local manufacturers, importers, and distributors on their specific local obligations, including the role of the Medical Device Registered Person (MDRP).

Furthermore, Focusedmedical offers bespoke training solutions. Simply choose a topic, outline your specific needs, and we will create a custom training session tailored to your requirements. This personalized approach ensures you gain the essential knowledge to successfully adapt to the EU Regulations."

"Our experienced consultants are equipped to carry out a comprehensive internal audit of your system, which can be conducted remotely or onsite. This audit aims to pinpoint any shortcomings in compliance with the specified requirements.

While such audits can be executed by your organization's Quality Department, engaging a third-party auditor offers the benefit of an unbiased and objective assessment.

Additionally, if your need is specifically for a thorough review of your quality documentation, we provide a detailed 'paper-review' gap assessment service. This service is focused on identifying any gaps or areas for improvement in your documentation."