Medical Devices are one of, if not the most, complicated, and tightly regulated products to place on the market within the European Union and the United Kingdom. This is not helped by the change from the Medical Device Directive to the new Medical Device Regulations which come into force in May 2021. This has been further complicated by Brexit as different regulations apply in different areas.
The first step is to identify if the product is actually a Medical Device and then which of the Regulation actually applies. Keep reading, and learn what you must know in this article written by International Associates Limited in the UK.
What is the definition of a medical device in the EU?
The Medical Device Regulations are very specific as to what is included and not include and define
‘medical device’ as meaning any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
1. diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
2. diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
3. providing information by means of in vitro examination of specimens derived from the human body,
including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
Hence this includes items that people may not usually consider such as Spectacles.
Once your product is classed as a Medical Device you also need to confirm which “class” it falls into. (Class I, Is, Ir, II, IIb, III) the higher the class the more complex the compliance that applies and which conformity assessment process you have to follow.
Do all medical devices require an Authorised Representative?
Basically, the short answer is yes, if you are a manufacturer outside the EU you need an EU Authorized Representative and if you are outside the UK you need a UK Responsible Person, the role of both of these is actually the same.
Which companies need an European Representative?
If you are a legal manufacturer placing on the market and CE marking the product, then you need an EU Rep or UK RP.
Regardless of whether you are passing through a distributor or other entity. The only exception to this would be if you are acting as an “OEM” Original Equipment Manufacturer for an EU or UK-based company that is adopting the role of Legal Manufacturer.
If you are selling to a EU or UK based company who is simply selling on through an online platform such as FBA then it is unlikely that they will be able to be the legal manufacturer as they will not have sufficient technical information to be able to do this.
What is the role of the Authorised Representative?
There are many parts of the Directive that can be completed by the Representative Company, however most companies only what then to complete the legal minimum, as to complete all requirements would be excessively expensive. Hence our recommended scope would be
- Verify the Declaration of Conformity
- Review the Technical Documentation
- Check where applicable that an appropriate conformity assessment exists
- Keep the previous documentation (Declaration of conformity, Technical Documentation, certificates issued by Notified Body and amendments) at the disposal of competent authorities (at least ten years and for implantable devices, it’s 15 years)
- Record Retention and Document control, including version controls.
- Ensure Labelling is correct and includes the details of the Authorised Representative.
- Verify that the manufacturer is complying with the registration of the Unique Device Identification according to article 27
- Make sure that the registration of the device is performed according to article 29, Register on EUDAMED for the EU, HPRA for the EU or MHRA for the UK.
- Also that the registration of the manufacturer, Authorized Representative, and importers are done according to article 31
- In case requested by the competent authorities, the Authorized Representative should give all the information and documentation necessary to prove the conformity of a device, in an official language
- Keep the manufacturer informed of any request coming from the competent authorities.
- Verify that the competent authorities receive the samples or is given access to the device.
- Cooperate with the competent authorities for any preventive or corrective action taken to cut or mitigate the risks posed by devices
- Immediately tell the manufacturer about complaints and reports from healthcare professionals, patients and users related to suspected incidents performed by their device.
How much does it cost?
In terms of the costs, it is approximately €1000 / device or group / year. This would typically be based on the items, which are covered by a single technical file or designed within range and classed as a group in terms of the Notified Bodies Certification (or GMDN Number). However, there are discount options for multiple devices, and if you require both UK and EU versions together, the fees can be reduced.
There is also an additional one-off registration fee, all products must be registered with the Regulatory Authority, such as the MHRA in the UK, and there is a fee charged by them to do this.
What kind of documents do I need to provide to the Authorised Representative?
There is a significant list of documents that must be supplied as part of the process, The Authorized Rep must hold this technical file and have it “Available” on request by a Regulator Authority, either in case of a Vigilance issue or as part of any audit of the Authorized Rep. The Regulatory Authority can simply turn up at the office of the Rep and demand to see the Technical File.
The Directive actual confirm what documentation must be within the Technical file, the main items include
- A general description
- Statement of intended use
- Classification details
- Description of Raw materials
- Labels and IFU (Instructions for use)
- Quality Management system documents (or Certification such as ISO13485)
- Design Information
- Manufacturing Processes
- Risk Analysis (eg, ISO 14971)
- Test reports and clinical evaluation
- Safety and clinical data
- Periodic Safety Update Report
- Declaration of Conformity
- Post Market Surveillance Information
- Notified Body certificate, if applicable
How can International Associates help companies in need of these services?
International Associates Limited is a Certification Body carrying out Quality Management System Certification of companies to ISO 13485 for Medical Devices; we are also carrying out Labour Standards Audits on behalf of the National Health Service hence we are very familiar with regulatory requirements relating to Medical Devices.
We have a UK based office and also a branch based in Ireland allowing us to offer both UK and EU compliance at the same time.
We also meet the regulatory requirements for acting as a Rep as defined regarding having a “PRRC Person Responsible for Regulatory Compliance“
We are members of TEAM PRRC, European Association of Persons Responsible For Regulatory Compliance Of Medical Devices.
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