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TECHNICAL LETTERS

November 19, 2020 | Spare parts, repair, refurbishments vs. “fully refurbished” – MDR article 23 and related

Where lies the boundary between “spare part” and “accessory for a medical device? When is repair considered equivalent to “fully refurbishing”? This Tech Letter aims at clarifying the definitions for these terms and determining the possibilities that remain for health care institutions.

October 9, 2020 | Control of outsources design & development activities

This Tech Letter aims to present the different possible approaches that may be applied and the associated risks incurred, as well as at presenting Medidee’s recommendations for MedTech companies considering to outsource D&D activities.

September 28, 2020 | GSPR 12. Requirements for devices incorporating active substances or substances absorbed by or locally dispersed in the human body

Manufacturers producing substance-based medical products are often confronted with the question of finding which European legal framework is applicable. Depending on the mode of action, their product can be regulated by the Directive 2001/83/EC relating to medicinal products for human use (MPD) or by the Medical Device Regulation 2017/745 (MDR). The objective of this document is to support manufacturers in this process.

September 21, 2020 | Future classification of IVD instruments

The new Regulation 2017/746 on in vitro diagnostic devices (IVDR) will enter into force on May 26th, 2022. The IVDR introduces a rule-based risk IVD device classification system aligned with what is applied for medical devices.  This Tech Letter will discuss the future classification of IVD instruments under the IVDR 2017/746 regulation.

September 14, 2020 | Claims and their substantiation

The claims made by a manufacturer regarding the intended use, safety, and performance of their medical device or IVD medical device, indubitably play an important role toward the commercial success of their product. This Tech Letter will discuss MDR/IVDR Article 7 and its implications in terms of the safety and performance data required to substantiate a given claim.

September 6, 2020 | ISO 14155:2020

The new ISO 14155:2020 – Clinical investigation of medical devices for human subjects – Good Clinical Practice was released in July 2020. We discuss in this Tech Letter the major changes to be aware of when planning, designing or conducting a clinical investigation.

August 21, 2020 | Placing on the market a system or procedure pack assembled by a company based outside the EU

The case of the placing of a system or procedure pack on the market where the system or procedure pack assembler is located outside of the EU is not covered in the MDR. It notably remains unclear whether the obligations of a manufacturer apply to the latter so long as the resulting system or procedure pack remains within the scope of Article 22(1). This article aims to clarify this question and will in addition provide a review of the registration requirements of Articles 29 and 31 applicable to system or procedure pack manufacturers, including those established outside the EU.

August 14, 2020 | MDR Article 22 – Systems and Procedure Packs

The European medical device legal framework defines systems and procedure packs, and furthermore determines requirements that apply to natural or legal persons when combining a medical device with other devices or products in different configurations. This article discusses the obligations incumbent on system and procedure pack manufacturers as well as the main differences between the provisions of the MDR and those of the MDD.

August 7, 2020 | EUDAMED – EMDN and CND nomenclature

In preparation of the arrival of EUDAMED, medical device nomenclature plays an important role. This article discusses briefly EUDAMED obligations in general and explains the nomenclature system that will be used in particular.

July 31, 2020 | EC-REP: Responsibilities, mandate and joint liability

This article discusses the responsibilities of an EC-REP and further focusses on the setup of the mandate binding the manufacturer and the EC-REP. It will also elaborate on the EC-REP’s joint liability with the manufacturer for defective devices provided for by the MDR and IVDR.

July 21, 2020 | ISO 20417: Information to be supplied by legal manufacturer

Information supplied by the legal manufacturer is a key aspect to ensure the safe and effective usage of the medical device by its intended user and contributes for minimizing the possibility of user errors.

July 10, 2020 | PRRC function and liability

This article aims to discuss PRRC qualification requirements and PRRC function, as well as to clarify the legal liability of PRRCs.

July 6, 2020 | Article 16 and distributor / importer certification

The objective of this Tech Letter is to clarify this article 16 and notably what a distributor or importer is or is not allowed to do in terms of relabeling and repackaging, as well as when certification is required.

June 26, 2020 | Distributor duties, distributor qualifications and quality agreements

Distributors have responsibilities toward making a device available on the market. This article discusses the obligations lying with the distributor and ways for a manufacturer to ensure that a distributor is qualified to meet these requirements.

June 19, 2020 | Importer Duties

The question of whether imported medical devices are required to transit through the importer is a recurrent one. This article aims to clarify this comprehensively, as well as to provide an outlook on the need for quality agreements between the manufacturer and the importer.

June 12, 2020 | Placing on the market, making available, and putting into service

when it comes to determine what activity is done by whom in a distribution chain, one can struggle to get a clear picture of the delimitation of the duties between market operators.

WHITE PAPER

May 4, 2018 | Technical Documentation and Medical Device Regulation

A Guide for Manufacturers to Ensure Technical Documentation Complies with EU Medical Device Regulation 2017/745.