Public consultation on MDR Annex XVI Implementing Regulation open! · MDlaw – Information platform on European medical device regulations

The European Commission has opened the public consultation on the draft Commission Implementing Regulation (CIR) and its Annex concerning the common specifications for products listed in Annex XVI of the Medical Devices Regulation 2017/745 (MDR). These devices are products with an aesthetic or non-medical purpose. They include materials used in cosmetic surgery (such as implants, dermal fillers, etc.) and contact lenses, body hair removal, and electrical brain stimulators, among others. Following the MDR, the CIR divides groups of products into seven Annexes:

Annex I will apply to groups of products without an intended medical purpose;
Annex II will apply to contact lenses specified in Section 1 of Annex XVI;
Annex III will apply to products intended to be totally or partially introduced into the human body, except tattooing products and piercings;
Annex IV will apply to substances or combinations of substances to be used for facial or other dermal or mucous membrane filling;
Annex V will apply to equipment intended to be used to reduce, remove or destroy adipose tissue;
Annex VI will apply to high intensity electromagnetic radiation emitting equipment intended for use on the human body;
Annex VII will apply to equipment for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity;

Scope

The Common specification in the CIR cover the requirements set out in MDR Annex I: the second sentence of Section 1 and in Sections 2 to 5, 8, and 9:

Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art.

2.	The requirement in this Annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio.

Manufacturers shall establish, implement, document and maintain a risk management system.

Risk management shall be understood as a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating. In carrying out risk management manufacturers shall:

(a) establish and document a risk management plan for each device;

(b) identify and analyse the known and foreseeable hazards associated with each device;

(c) estimate and evaluate the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse;

(d) eliminate or control the risks referred to in point (c) in accordance with the requirements of Section 4;

(e) evaluate the impact of information from the production phase and, in particular, from the post-market surveillance system, on hazards and the frequency of occurrence thereof, on estimates of their associated risks, as well as on the overall risk, benefit-risk ratio and risk acceptability; and

(f) based on the evaluation of the impact of the information referred to in point (e), if necessary amend control measures in line with the requirements of Section 4.

Risk control measures adopted by manufacturers for the design and manufacture of the devices shall conform to safety principles, taking account of the generally acknowledged state of the art. To reduce risks, Manufacturers shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable. In selecting the most appropriate solutions, manufacturers shall, in the following order of priority:

(a) eliminate or reduce risks as far as possible through safe design and manufacture;

(b) where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated; and

Manufacturers shall inform users of any residual risks.

In eliminating or reducing risks related to use error, the manufacturer shall:

(a) reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and

(b) give consideration to the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or other users).

All known and foreseeable risks, and any undesirable side-effects, shall be minimised and be acceptable when weighed against the evaluated benefits to the patient and/or user arising from the achieved performance of the device during normal conditions of use.

For the devices referred to in Annex XVI, the general safety requirements set out in Sections 1 and 8 shall be understood to mean that the device, when used under the conditions and for the purposes intended, does not present a risk at all or presents a risk that is no more than the maximum acceptable risk related to the product’s use which is consistent with a high level of protection for the safety and health of persons.

Risk management and ”information for safety”, which include warnings to be included on the device manual (IFU), are further governed in the Annexes of the Commission Implementing Regulation. For exeample Annex II applies to MDR Annex XVI contact lenses and requires from a manufacturer – among others – to include on the product label a warning “Used lenses shall not be used by other persons.”, Do not contaminate lenses with make-up or aerosols.”, information on how to report undesirable side-effects to the manufacturer., etc.

Timeline

According to Article 1(2), the MDR shall apply to products listed in Annex XVI six months from the publication of the Common specifications. The draft CIR proposes to extend the time frame and provide more time to certain manufacturers, i.e.:

Where clinical investigations have to be performed to confirm the conformity with the relevant general safety and performance requirements: placing on the market until 3 years after the CIR date of application (CIR DoA) provided that:
- the product was already lawfully marketed in the Union before the CIR DoA & continues complying with the requirements of Union and national law that were applicable before the CIR DoA and
- There are no significant changes in the design and intended purpose of the product.
Where a notified body has to be involved in the conformity assessment procedure: placing on the market until 1 year after the CIR date of application (CIR DoA) provided that:
- the product was already lawfully marketed in the Union before the CIR DoA & continues complying with the requirements of Union and national law that were applicable before the CIR DoA and
- There are no significant changes in the design and intended purpose of the product.

Yet, the manufacturers will not be able to benefit from additional time in case they would not notify a clinical investigation/receive a confirmation from a Competent Authority /and start the trial within a ”reasonable timeline” [proposed timeline is set at up to one year/ 18 months/ and three years]. Similarly, the manufacturer will need to apply for an assessment to a notified body and sign an agreement within one year from the CIR DoA as per the draft text.

The feedback period on the draft CIR is open until the 11th of February 2022. You can provide your opinion via the following link.

You can find this CIR as well as other documents in our dedicated Library!

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