Things to keep in mind for 2023!

We expect many developments within our field of expertise for 2023. These are the main developments of which we are certain that they will impact you. In this blogpost we will briefly explain what changes will occur, how this will impact you, and how we can help you handle them. You can expect more detailed information from us in the upcoming year, as the developments take place.

The highlights are:

• New services
• New Machinery regulation
• Medical device regulation postponed
• UKCA Marking extended deadline

New Services

Through our fusion with Kader, we have acquired an extensive machinery and medical team and can therefore offer more services within the upcoming year.

Machinery team:

Because our machinery team has started collaborating with the team of Kader Group, it is able to take on new challenges that revolve around ATEX, an Inspection Plan, Functional Safety (Performance Level and Safety Integrity Level) and LOTOTO (Lock Out, Tag Out, Try Out).

Medical team:

Similarly, our medical team fused with the team of Kader Group, allowing us to now provide additional services:

• Implement a Quality Management System (QMS), according to Article 10 of the Medical Device Regulation, ISO 13485 or ISO 9001.
• Become your PRRC (Person Responsible For Regulatory Compliance) and/or your deputy PRRC – The PRRC is appointed by both manufacturers and Authorised Representatives (AR). Identifying the PRRC for your organisation is an important requirement of the Medical Device Regulation 2017/745 in the European Union and is a core area of responsibility for a person under the medical device regulation. The deputy PRRC consists of a backup for the official PRRC, where the backup PRRC only jumps in if there is an urgent situation while the formal PRRC is not available or not independent for a part of the tasks.
• Support with low-risk FDA submissions (510K Exempt).
• Guidance with GDP, which includes:
• Support with certification application
• Setting up a Quality Management System
• Responsible person
• Deputy responsible person
• Guidance with inspection
• GDP incompany training

AR (Authorised Representative) team:

Our AR team offers EU and UK Authorised Representation for all of your products, except for a few, among which: food, medicines, cosmetics, and chemicals. We offered these services last year too, but aim on bringing them even more into the foreground of our company, allowing us to take on even more of your AR challenges.

New Machinery Regulation

Machine regulation has been a topic of debate for a while and is currently in the midst of a developmental process.

The expected schedule:

• For Q3 and Q4 there are currently (2022) deliberations within the European council and parliament. Limited adjustments are expected.
• The machinery regulation will be adopted either in Q4 in 2022 or in Q1 in 2023.
• For Q2, the publication of the machinery regulation will take place in 2023.

Post publication, the transition period is estimated to be 30 to 36 months, meaning the Q1 – Q4 effective date will be in 2026.

The Machine Regulation will then have a completely new classification and will be based on the harmonisation of the other New Legislative Framework (NLF) regulations.

The main consequences of the new regulation:

• The list of machines that are categorised under ‘strong risk potential’ will change in the future, and will include more machines, meaning that the manufacturers of such machines will have to adhere to stronger risk management requirements.
• Due to the fact that there will be more machines with ‘strong risk potential’, the requirement to call in notified bodies will apply to more machines. This will result in higher conformity evaluation costs.
• There will be new requirements for secure technology in relation to cyber security and artificial intelligence (AI).
• Official reporting obligations will be introduced for machines in the field that constitute risk. Likewise, new obligations for distributors will be introduced, which, on the other hand, offer more legal certainty on the whole for the industry.
• Manufacturers may issue digital instructions, but they need to keep significant restrictions in mind.
• Software that provides a safety function will be included within the definition of the safety components.
• In the event of conformity with technical specifications or parts thereof, the presumption of conformity shall also be enabled.

What can Certification Experts do?

Our experts offer complete guidance regarding the CE marking for Machinery and can therefore help you to demonstrate your machines’ compliance with the Machinery Directive. We will keep our knowledge up to date and will keep up with the transition phase of the Machinery Regulation, so we can help you prepare to ensure compliance with this upcoming Machinery Regulation.

Medical Device Regulation postponed

Recently, the EU Council decided to support a proposal to postpone the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR).

The expected schedule is:

• Medical devices of Class I and Class IIa, will be reclassified under the MDR. Some Class I medical devices are upclassified under the MDR and therefore moved to a higher risk class. The manufacturers of these upclassified Class I devices and Class IIA devices now have until the 26th of May 2028 to prepare their technical documentation to comply with the Regulation (EU) 2017/745 and certify their devices at the Notified Body.
• Manufacturers of Class IIb and III devices now have until the 26th of May 2027 to prepare their documentation to comply with the Regulation (EU) 2017/745 and certify their devices at the Notified Body (NoBo).

Note! The extensions are only applicable for manufacturers whose devices do not have safety signals from PMS data, who have executed NoBo application for conformity assessment before May 2024 and/or who had their QMS certified under the MDD before the same date.

The main consequences:

Although this means that manufacturers have more time to get their conformity assessment in order, it is important to take into account that many manufacturers must do so. The MDR simply has more requirements that must be met, which takes more time and are largely dependent on the services of external parties. It is already a lengthy process and many NoBo’s have their hands full with their current clients. You do not want to be kept waiting, so we strongly suggest you start your MDR compliance process as soon as possible.

What can Certification Experts do?

Our Medical team has MDR experts who can help you with:

• The transition from conforming from the MDD to the MDR. This will enable your medical devices to be in compliance with the new regulation.
• Finding out in which class your medical product belongs to and, accordingly, which regulations apply to it. We will aid you in finding the right Class by means of our Classification Assessment.
• Registering your company as well as its medical devices in the new system of EUDAMED and UDI-registration. We can help you to get this done quickly and efficiently.
• Checking whether your Technical Files are in order with regulatory requirements. Certifications Experts offer a thorough review of this documentation and will assist you to gather all the relevant information necessary to compile these files (Labels, IFU, DoC, GPSR, etc.).
• Deciphering the different regulations that a company must adhere to. It might be the case that you must have your products tested and certified by a third party: a NoBo. However, it is not mandatory to have a NoBo that is located in the Netherlands. Certification Experts can take on this search for you and help you find a NoBo that is right for your company whilst taking care of the necessary administrative business.
• By becoming your EC REP/UKRP in order to help you to be able to enter the European and United Kingdom markets if your company is located outside of the EU or UK. Additionally, we can also conduct the Registration of Class I Medical Devices.
• Getting through the introduction of the ISO 13485, which has repercussions for the regulations concerning your Quality Management System (QMS). For advice on whether your company needs to adhere to Article 10 of the MDR, the ISO 9001 or the ISO 13485, you can contact Certification Experts. We can then also help you to transform your QMS to comply with the corresponding regulation.
• With the MDR regarding its newly introduced regulations concerning a company’s software programs. The software needs to be tested before it can be verified as safe, which then also needs to be documented. This too, is a procedure that we can guide you through.
• By means of offering Training done by our experts and based on ‘Compiling the Technical Documentation’ and ‘Developing a Medical Device’ or based on the quality management system like ISO 13485.

UKCA Marking extended deadline

The UKCA marking will replace the CE mark as part of Great Britain’s plan for the post-Brexit product safety framework. The deadline to get your products UKCA marked has recently been extended, which means that CE marking will be recognised until the 31st of December 2024. As of 2025, your product must thus be UKCA marked to be traded on the UK markt.

The expected schedule:

• The use of the new UKCA marking will be mandatory as of 31 December 2024
• Companies are able to affix the UKCA mark and include importer information for products from EEA countries on an accompanying document or label until 31 December 2027
• The government will also allow conformity assessment activities for CE marking undertaken by 31 December 2024 to be used by manufacturers as the basis for the UKCA marking until 31 December 2027

The main consequences:

Businesses will be given an additional two years to apply to the UK Conformity Assessment (UKCA) marking to their products.

• The period that a CE mark may be applied to products being placed on the market will be extended until 31 December 2024
• This extension will be implemented alongside two other measures that will be implemented to reduce the costs of retesting products and labelling
• To reduce labelling costs, the government will allow businesses to affix the UKCA mark and include importer information for products from EEA countries on an accompanying document or label until 31 December 2027

What can Certification Experts do?

As new UK marking directives and regulations are being made and implemented, our experts are working to gain the necessary knowledge to be able to provide assistance. With 2023 around the corner, our experts will greet you with the needed knowledge and be ready to help you. We will help you obtain UKCA marking so you can enter the UK market with your products. We offer complete certification guidance and expert services in order to ensure your product is compliant with the UKCA marking legislation. We offer:

• Consultancy and advice on problem solving
• Authorised Representative services (UK AR/UKRP)
• A stipulated route to compliance
• An overview of the applicable standards, directives and regulations
• Guidance in the conformity assessment procedure (with accredited third-party)
• To perform the required product testing
• On-site inspections
• Design review
• Support with technical documentation
• To perform risk assessment