The new EU regulations for medical devices – MDR, IVDR – have introduced stricter requirements for the EU Authorised Representative. We look at the key requirements and introduce Avoca Terrigal S.R.L. our EU-based partner for EU Authorised Representative services.

By Val Theisz

The EU Medical Devices Regulation or MDR and the In Vitro Diagnostic Medical Devices Regulation or IVDR introduced more stringent requirements for EU Authorised Representatives. These are outlined in Article 11 of the MDR and IVDR.

While in the past designation of EU Authorised Representatives could be done simply by issuing a letter by the non-EU manufacturers, the new regulations stipulate that the designation must be done via a “mandate” that is valid only when accepted in writing by the Authorised Representative.

The mandate must require, and the manufacturer must enable, the Authorised Representative to perform at least following tasks:

1. verify existence of EU declaration of conformity (DoC) and technical documentation and, where applicable, check appropriateness of the conformity assessment procedure carried out by the manufacturer;
2. keep available a copy of the technical documentation, the EU DoC and, if applicable, a copy of the relevant certificate, including any amendments and supplements at the disposal of competent authorities for the required period;
3. comply with the registration obligations regarding Single Registration Number (SRN) and verify manufacturer compliance with the registration obligations regarding Unique Device Identification System (UDI) and Eudamed;
4. respond to competent authorities’ requests with information and documentation necessary to demonstrate the conformity of a device;
5. forward to the manufacturer any request by a competent authority of the Member State in which the authorised representative has its registered place of business for samples, or access to a device;
6. cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;
7. 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;
8. terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.

The overseas manufacturers may delegate some but not all their obligations to their EU Authorised Representatives. The following manufacturer’s obligations may not be delegated to the EU Authorised Representative:

• ensure that medical devices have been designed and manufactured in accordance with the requirements of MDR/IVDR when placing them on the market or putting them into service;
• establish, document, implement and maintain a system for risk management as described in the MDR/IVDR;
• conduct a clinical evaluation in accordance with the requirements set out in the MDR/IVDR.
• draw up and keep up to date technical documentation for medical devices other than custom-made devices, to allow the conformity assessment of the device with the requirements of the MDR/IVDR;
• draw up a DoC and affix the CE marking of conformity to show compliance of medical devices, other than custom-made or investigational devices, with the applicable general safety and performance requirements (GSPR);
• comply with the obligations relating to the UDI system and with the Eudamed registration obligations;
• establish, document, implement, maintain, keep up to date and continually improve a quality management system for mass production and design change management in compliance with MDR/IVDR in a manner that is proportionate to the risk class and the type of device
• implement and keep up to date the post-market surveillance system in accordance with MDR/IVDR requirements;
• comply with the requirements for information supplied with the device in an official Union language(s) determined by the Member State in which the device is made available to the user or patient;
• take the necessary corrective action regarding non-conforming devices placed on the market or put into service, and inform the distributors of the device in question and, where applicable, the authorised representative and importers accordingly

Market Access (AUS) collaborates with EU-based Avoca Terrigal S.R.L. to provide EU Authorised Representative services to our MedTech start-ups (note the unmistakable Australian connection in the name!). Avoca Terrigal S.R.L. is registered in Eudamed under Actor ID/SRN RO-AR-000034301.

Market Access (AUS) and Avoca Terrigal S.R.L. are independent services providers, we are not involved in the sale or distribution of medical devices anywhere in the world, which ensures we are completely independent and free from conflicts of interest.

Manufacturers may change to another EU Authorised Representative if they so wish. The arrangement for a change of authorised representative must be detailed in an agreement between the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised representative.

The agreement must cover at a minimum the following aspects:

1. the date of termination of the mandate of the outgoing authorised representative and date of beginning of the mandate of the incoming authorised representative;
2. the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material;
3. the transfer of documents, including confidentiality aspects and property rights;
4. the obligation of the outgoing authorised representative after the end of the mandate to forward to the manufacturer or incoming authorised representative any complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device for which it had been designated as authorised representative.

Further information on EU Authorised Representatives, Importers and Distributors: European Commission Factsheet

Managing medical devices end of life cycle – August 2023

Premarket requirements and placing products on the market are typically the focus of medical device businesses. But managing the end of lifecycle of medical devices – safe disposal and recycling – has increasingly become a compliance issue, both in relation to latest medical device regulations and local environmental and health regulations.

By Val Theisz

Once ownership of medical devices changes hand from manufacturers or distributors to healthcare organisation and end consumers, manufacturers no longer have control on what happens to used medical devices and how these are discarded or recycled. But does that mean manufacturers have no responsibility for managing the end of lifecycle of their products? Not quite. Medical device regulations include requirements for managing the product end of life.

For example, the EU Medical Devices Regulation or MDR and the In Vitro Diagnostic Medical Devices Regulation or IVDR include requirements for the safe disposal of medical devices in Annex I General Safety and Performance Requirements or GSPRs (emphasis added):

EU MDR:

13.3. For devices manufactured utilising non-viable biological substances other than those referred to in Sections 13.1 and 13.2, the processing, preservation, testing and handling of those substances shall be carried out so as to provide safety for patients, users and, where applicable, other persons, including in the waste disposal chain. In particular, safety with regard to viruses and other transmissible agents shall be addressed by appropriate methods of sourcing and by implementation of validated methods of elimination or inactivation in the course of the manufacturing process.

14.7. Devices shall be designed and manufactured in such a way as to facilitate their safe disposal and the safe disposal of related waste substances by the user, patient or other person. To that end, manufacturers shall identify and test procedures and measures as a result of which their devices can be safely disposed after use. Such procedures shall be described in the instructions for use.

23.4. Information in the instructions for use

The instructions for use shall contain all of the following particulars:

(v) warnings or precautions to be taken in order to facilitate the safe disposal of the device, its accessories and the consumables used with it, if any. This information shall cover, where appropriate:

— infection or microbial hazards such as explants, needles or surgical equipment contaminated with potentially infectious substances of human origin, and

— physical hazards such as from sharps.

If in accordance with the point (d) of Section 23.1 [General requirements regarding the information supplied by the manufacturer] no instructions for use are required, this information shall be made available to the user upon request;

EU IVDR:

13.6. Devices shall be designed and manufactured in such a way as to facilitate their safe disposal and the safe disposal of related waste substances by users, or other person. To that end, manufacturers shall identify and test procedures and measures as a result of which their devices can be safely disposed after use. Such procedures shall be described in the instructions for use.

20.4.1. The instructions for use shall contain all of the following particulars:

(ac) warnings or precautions to be taken in order to facilitate the safe disposal of the device, its accessories, and the consumables used with it, if any. This information shall cover, where appropriate:

(i) infection or microbial hazards, such as consumables contaminated with potentially infectious substances of human origin;

(ii) environmental hazards such as batteries or materials that emit potentially hazardous levels of radiation);

(iii) physical hazards such as explosion.

Similar requirements are defined in the Australian Medical Device Regulations, in Schedule 1 Essential Principles:

9.2 Minimisation of risks associated with use of medical devices

(h)  the risks associated with disposal of any waste substances.

13.4  Instructions for use

26 Information about precautions that should be taken by a patient and the user if there are special or unusual risks associated with the disposal of the device

In the U.S., the FDA regulation 21 CFR Part 801 Labeling does not cover instructions for safe disposal of medical devices, as waste handling including safe disposal of medical devices is managed at State level.

In addition to medical device regulations, manufacturers need to be aware of state and national environmental, packaging labelling and waste disposal regulations in the market they place their devices on.

In the EU, the key environmental Directives are:

• Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS) – The RoHS aims to prevent the risks posed to human health and the environment related to the management of electronic and electrical waste by restricting the use of certain hazardous substances such as heavy metals, flame retardants or plasticizers, that can be substituted by safer alternatives.
• Waste from Electrical and Electronic Equipment (WEEE) – The WEEE aims to address environmental and sustainability issues caused by the growing number of discarded electronics, also referred to as electronic waste or e-waste, by preventing e-waste where possible, and setting targets for re-use, recycling and other forms of recovery.
• Batteries Directive and New EU regulatory framework for batteries – The Battery Directive aims to minimise the negative impact of batteries and waste batteries on the environment, by setting limits to hazardous substances in batteries such as mercury, cadmium and lead, and to set rules for the proper management of waste batteries.
• Packaging Waste – The Packaging Waste Directive aims to prevent the generation of packaging waste, reducing it in quantity, and promoting reuse and refill and increase the use of recycled plastics in packaging, thus enabling more high quality (“closed loop”) recycling and substituting virgin materials.

In Australia, attempts were made to introduce recycling schemes such as the Australian Packaging Covenant and REDcycle, with limited success (to put it mildly). An official review in April 2023 found Australia was recycling just 18% of plastic packaging and would fall well short of a target of 70% by 2025. In June 2023, the States and Territories environment ministers issues a Communiqué in which they agreed to:

• Take shared action to address the biodiversity crisis by setting ambitious national targets, in line with the Global Biodiversity Framework, by mid-2024
• By 2024 develop a roadmap to protect and conserve 30% of Australia’s land
• Strengthen Australia’s marine protection, and identify shared marine and coastal protection, pollution abatement and restoration actions to include in a national Sustainable Ocean Plan

An alignment with EU environmental regulations, or at least avoiding a completely divergent Australian environmental regulatory framework, would be beneficial to medical device manufacturers and importers as it would mean designing and labelling medical devices including packaging to meet a set of convergent if not harmonised environmental regulations (Australian medical device regulations are aligned with EU MDR and IVDR after all).

Here are a few strategies that developers of medical devices can adopt:

• Train systems engineers to identify applicable regulatory requirements, including environmental requirements, early into the product development process
• Wherever possible, use fewer materials, select materials that are attractive in terms of recovery, choose design solutions that allow materials to be easily separated from each other
• Wherever possible, choose design solutions that allow easy decontamination of products after use, so that materials can be cleaned and recovered or recycled
• Apply recycling and disposal labels, as appropriate; include instructions in the user manual to remind users to dispose of the medical device in accordance with the local environmental regulations.

Further information on waste and recycling: Waste and recycling – DCCEEW