EU MDR info sessions, webinars and trainings often focus on the big MDR picture: general requirements, known definitions, most common prerequisites and most essential obligations of the operators.
Sure they constitute significant MDR infrastructure especially for medical device manufacturers.
It’s however a good idea to also pay attention to less known, but just as important elements in MDR’s shadows. They need to be evaluated too and, if appropriate, fulfilled by MDR date of application May 26th 2021. Otherwise, there’ll be gaps in MDR compliance.
You don’t want your competitors to rub them in, the competent authority to order you to fix them immediately or the notified body to postpone MDR CE-certificate’s approval you’ve waited for so long?
Let’s take a look at what you need to know to avoid the pitfalls.
* * * PLEASE NOTE: This post is available also in Finnish Varoitus: Ethän unohda näitä EU MDR detaljeja
Declaration of Conformity
MDR annex IV states that device’s EU declaration of conformity shall refer to every EU legislation that provides for the issuing of an EU declaration of conformity and whose requirements cover the device in question. This means, depending on the device, that EU MDR regulation (EU) 2017/745 may not be sufficient in declaration of conformity.
Examples of other Union legislation which may impact medical devices:
- EU Machinery Directive 2006/42/EY
- REACH Regulation 1907/2006 for chemicals
- RoHS Directive 2011/65/EU which restricts the use of hazardous substances in electrical and electronic equipment
Manufacturer needs to assess whether for example the above-mentioned legislation affects their medical devices and do they need to take action based on their conformity.
Please note also MDR article 19: a single EU declaration of conformity shall be drawn up in respect of all Union acts applicable to the device.
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Authorised Representative vs. Manufacturer
Manufacturer located outside the EU must appoint an authorised representative in the Union to represent them. Authorised representative has many obligations, as it says in article 11. These obligations don’t however free the manufacturer from many of the obligations still on their plate.
According to article 11 manufacturer shall, in any case, take care of MDR-compliant device design and manufacturing, risk management, clinical evaluations, technical documentation, EU conformity assessment, its assurance and affixing CE marking on the device, UDI, series production in conformity with the requirements of MDR, change management, quality management system, post-market surveillance, labelling and other information provided with the device in required languages, and corrective actions.
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Translations
Article 19.1 states that EU declaration of conformity needs to be translated into the official languages of Union member countries where the device is made available.
In connection with serious incidents and field safety corrective actions, field safety notices must be submitted in the national languages of the EU member country where the corrective action is conducted (article 89).
The information provided to the patient on an implant card must be presented in the language of the EU member country in question (article 18).
The information supplied with the device (e.g. labelling and instructions for use) shall be translated into the official languages of the EU member countries where the device is made available to the user or patient (article 10).
So an English version of the above-mentioned documents or content won’t do, unless it’s the national language of the country in question or the use of English is allowed otherwise.
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Notified Body for Class I Devices
Class I devices are normally certified by manufacturers themselves. If class I devices are however placed on the market sterile, with a measuring function or they are reusable surgical instruments, manufacturer needs a notified body to conduct conformity assessment. According to article 52, notified body’s involvement is nevertheless limited to only those procedures that are in the scope of sterility, measuring and reusability.
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Labelling on Manufacturer’s Website
Annex I, chapter III says that manufacturer has to provide device’s and manufacturer’s identification information as well as device’s essential safety and performance information with the device. In addition to device, packaging and instructions for use, if the manufacturer has a website, the information (labelling) needs to be made available there too and kept up to date.
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Instructions for Use
Instructions for Use don’t need to be supplied with class I and IIa devices, according to annex I, chapter III, if they can be used safely without them and unless otherwise provided for elsewhere in the MDR section. Leaving out the instructions does require a rationale from the manufacturer, which needs to be made clear at least in the device’s risk management. If the device is reusable and it must be sterilised before reuse, instructions are undoubtedly required.
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Document Retention
Anned IX, chapter III describes that a manufacturer – or in the case of a non-EU manufacturer, an authorised representative – is obliged to keep EU declaration of conformity, critical quality management system or device change approval documents and possible decisions and reports of the notified body at the disposal of authorities for 10 years after that last device has been placed on the market, or 15 years in case of implantable devices.
Because we’re talking about a long time, and should anything happen to the company – for example its business would come to an end – it’s important to make a plan on how to look after the statutory document retention period.
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Person Responsible for Regulatory Compliance
According to article 15, a manufacturer must have in their organisation or at their disposal at least one person responsible for regulatory compliance. Authorised representative shall have this person permanently and continuously at their disposal. The person needs to be documented not only in the manufacturer’s and authorised representative’s quality management system, but, per annex VI, part A, also into Eudamed. The name, address and contact information of the person responsible for regulatory compliance need to be submitted to Eudamed in the manufacturer’s registration and kept up to date there.
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Device Maintenance and Repair
Some medical devices need scheduled maintenance and replacement of parts due to wearing out or breakdown. Manufacturers of such devices may therefore offer their own servicing to their customers. Article 23 is as far as I can see the only place in MDR where maintenance/servicing and repairing are addressed. It says that replacing a broken or worn out part/component shall be carried out so that the device’s safety and performance are not negatively affected. Furthermore, the evidence must be kept for the authorities just in case.
Manufacturer has to ensure not only the conformity of the spare parts, but also document in the quality management system the processes for maintenance and repair staff. Does your service staff know MDR requirements? If they notice a sudden spare part need in the device during scheduled maintenance, but original spare part is unavailable, is it acceptable that they replace it with an equivalent part by the competitor (which you haven’t tested)? Or where does your service person document this: does the work mobile have a service app to submit the information to manufacturer’s quality management system? This is something the manufacturer should discuss with service.
Were you familiar with these details?
Can you think of any other little known MDR elements which you’d like to bring to the table?
Please leave your comments below, I’d be happy to read them!
Or would you like to talk about your company’s preparation for MDR?
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Do reach out – I look forward to helping you!
