Our Regulatory Affairs department is focused on medical device lifecycle compliance, including regulatory systems (EU, FDA), quality systems (ISO 13485, ISO 9001, FDA QSR), risk management (ISO 14971), product safety (IEC and ISO standards), product lifecycle testing and management, quality assurance and regulatory auditing.
Our team follows a risk-based regulatory strategy that uses regulatory compliance to fulfil the business needs in a structured way.
Covering a wide range of products, from simple bandages to the most sophisticated software, the medical devices sector plays a crucial role in the diagnosis, prevention, monitoring and treatment of diseases.
According to Medical Device Regulation (EU) 2017/745, ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the
following specific medical purposes:
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a medical device is in conformity with the applicable requirements set out in the Regulation and other applicable Union harmonisation legislation providing for its affixing.
CE marking indicates that your product has been assessed to meet EU safety, health and environmental protection requirements and that it can be freely traded within the European Economic Area (EU + EFTA countries).
CE marking is valid for medical devices developed both inside and outside the EEA. It is required for all products, including software/apps, that fall under the definition of a medical device.
When users download and install an app with a medical purpose – diagnose, treat, monitor or prevent a disease – they expect that the software will be safe and work properly.
If your mobile health app falls under the EU definition of a medical device, it must follow a conformity assessment and bear the CE mark to be placed in the EU market. This marking assures to users, health professionals and European authorities that adequate quality, safety and performance were taken into account as per EU law.
It is very important for your company to know how your app is regulated. Market surveillance authorities throughout the entire European Union monitor products to ensure they meet all health and safety requirements as declared by the manufacturer. Regulators are putting added pressure on medical device companies to demonstrate that their technologies perform safely and as intended
Development of quality system strategies to meet regulatory and quality requirements.
Performance of gap analyses, to identify improvement measures for compliance or to improve the efficiency of business processes.
We can provide gap assessment and assistance in the preparation of quality system procedures; QA advice and support during product design & development activities (design control); management of quality system certification and inspection processes, including coordination of audits & inspections by regulatory authorities; QA training.
Design, implementation and audit of quality management systems for conformity to ISO 13485
Guidance for successful implementation of Quality Management Systems ISO 13485
Management of software development projects fully compliant with:
ISO/IEC 27001 – Cybersecurity
Gap assessment and assistance in the preparation of quality system procedures.
Providing QA advice and support during product design & development activities (design control).
Management of quality system certification and inspection processes, including coordination of audits & inspections by regulatory authorities.
Providing QA advice and support in defining and implementing corrective & preventive actions (CAPA) in the case of deviations and quality improvement initiatives.
QA training.
Characterisation as a ‘medical device’ or ‘non-medical device’ is determined according to the intended purpose as defined by the manufacturer.
Intended purpose means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation.
Depending on the intended use of your app, it may be considered a medical device and be subject to the European Medical Device Directives / Medical Device Regulation requiring CE marking.
According to Medical Device Regulation (EU) 2017/745, ‘Authorised Representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under the MDR.
If your company does not have a physical location in the EU, you are required to appoint an Authorized Representative to represent your company to European Authorities. You must retain an Authorized Representative as long as you sell your medical devices in Europe.
Before placing a medical device on the European market, manufacturers need to produce Technical Documentation providing evidence of conformity with the relevant legislation.
The Medical Device Regulation (MDR) defines requirements for the Technical Documentation that has to be developed during the design and development process of a device and maintained throughout its entire life cycle.
The Technical Documentation must be kept in the premises of the manufacturer or the Authorized Representative in a clear, organized, readily searchable and available for the European Competent Authorities.
By drawing up the EU declaration of conformity, the manufacturer assumes responsibility for compliance with the requirements of the Medical Device Regulation and all other Union legislation applicable to the device.
The EU declaration of conformity shall contain all of the following information:
Conducting a clinical investigation in medical devices within the European Union (EU) requires a Sponsor, who has responsibilities before, during and after the clinical investigation.
The MDCG 2022-19 was published on December 2022. This document indicates a series of templates that should be used for performance study applications under the IVDR, while the respective EUDAMED module is not fully functional.
Safety reporting in clinical investigations of medical devices shall be performed in line with Article 80(2) of the EU MDR. On May 2020, it was published the MDCG 2020-10/1, outlining the procedures for safety reporting in clinical investigations of medical devices under the EU MDR. However, on October 2022 the Medical Device Coordination Group (MDCG) published an updated version of the MDCG 2020-10/1, the MDCG 2020-10/1 Rev 1. This article highlights the updates included in the new revision, analysing the gaps between both documents.
If a medical device manufacturer is not established in a Member State, the devices can only be placed on the Union market if the manufacturer designates an authorised representative. The authorised representative plays a pivotal role in ensuring the compliance of the devices with EU regulation, serving as point of contact. The obligations and responsibilities of authorised representative are outlined on Article 11 of both MDR and IVDR, but clarification of relevant requirements is described in MDCG 2022-16 of October 2022.
ISO Standards cover a huge range of activities, representing the distilled wisdom of people with expertise in their subject matter and providing the regulators with a sound basis to develop better legislation. ISO Standards are diverse, addressing from the shoe size we wear to the quality of air we breathe. The medical device sector is no exception. ISO has many International Standards and guidance documents aimed at helping the sector ensure safe and effective medical devices while meeting the multitude of national, regional and international regulatory requirements. But how exactly is a Standard developed, reviewed and withdraw?
The Commission published the Implementing Regulation (EU) 2022/2347, laying down rules for the reclassification of several active products without an intended medical purpose mentioned in MDR annex XVI.
