UK Responsible Person

• Make sure that the Notified Body is designated for the services required by you.
• Identify the scope of services of the potential Notified Bodies
• Confirm if the Notified Body that you have selected provides certification for the quality system along with certification of conformity assessment
• Check for the capability of a Notified Body to provide services that apply to regulatory jurisdictions outside Europe
• Inquire the audit method and regarding the stringency of the Notified Bodies before the selection to avoid risk to patients and medical device manufacturers
• Select the Notified Body at the earliest especially if the medical device is complex or if its regulatory status is not straightforward, which can occur with drug-device combination or borderline products
• Carefully review the contract between you and the Notified Body

In order to classify your product, the first step in EU regulatory process is determining which regulation is applicable to your product, that is, MDR 2017/745 or IVDR 2017/746. For the purpose of classification there are 22 rules in Annex VIII of the MDR

Classification are as follows:

• Class I– Provided non-sterile or do not have a measuring function (low risk)
• Class I– Provided sterile and/or have a measuring function (low/medium risk); the MDR adds reusable surgical instruments as Class I reusable surgical instruments, to this group.
• Class IIa(medium risk)
• Class IIb(medium/high risk)
• Class III(high risk)

According to MDR 2017/745, ‘Clinical Evaluation’ means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.

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The Technical Documentation or the Technical File refers to all the documents that the medical device manufacturers need to submit to the notified body as per the MDR or the IVDR.

The major contents of a technical documentation are:

• Identification of the medical device or the IVD (E.g.: UDI)
• Description of the device, including variants, configuration and accessories
• Intended purpose
• Labelling (Packaging, IFU etc.)
• Information on the design and manufacture
• Risk Management File
• Verification (Stability, Electrical safety tests reports and certificates and so on) and Validation (Clinical Evaluation, Biological Evaluation etc.) to prove that the medical device/IVD meets the general safety and performance requirements.

When you need to budget for medical device CE Marking, the following cost should be considered

1. Cost of testing as per the harmonized standard
2. Notified Body Fees including auditor travel
3. Consultants fees towards guidance and preparation of Technical File/Design Dossier
4. Annual Surveillance Audit
5. ISO 13485 Implementation and Certification Fee

1. Better understanding of your medical device and its applicable regulatory requirements faster than anyone
2. Always have prior experience in handling similar Medical Devices
3. Provide guidance and support in preparing Technical File /Design Dossier
4. We are experienced medical writers for developing clinical evaluation report as per MEDDEV 2.7/1 Rev. 4
5. Support in conducting the Risk Analysis and Usability Records
6. Experienced in Quality Management System implementation as per ISO 13485:2016
7. Identifies the applicable Harmonized standards
8. Have the necessary knowledge and expertise to review and comment external test reports
9. Reviews verification & validation documents and labels as per ISO 15223-1
10. Identifies the class and applicable rule of Medical Device
11. Can identify the main route of CE Marking
12. Well-experienced in preparing the Declaration of Conformity
13. Helps with identifying the Notified Body
14. Supports during certifications and annual surveillance audits
15. Others supports such as:
    1. Guidance on Implantable, Active Implantable, Animal Origin & Drug Device combination products
    2. Technical support for IVD Device
    3. Electro-Mechanical and ROHS, PED combination Devices as per 2007/47/EC.
    4. Software CE Marking

The EU Authorised Representative (E.A.R) is your link to European authorities, and they must have physical presence in Europe. They will enrol your medical device or IVD before it is marketed and will always be available to serve as a contact between you and the Competent Authorities of the EU member states. Your (E.A.R) will also have access to your Technical Documentation(s), which must be available for inspection by the Competent Authorities. In other words, a variety of the responsibilities of the manufacturer are delegated to the EU Authorised Representative.

By supporting on attaining the CE mark and QMS implementation, consultants play very crucial roles in assuring CE certificate from the Notified Bodies.

Yes, the Consultants guide the manufacturers by informing which harmonized standard testing has to be done and which Labs are to be approached.

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As the conformity assessment routes include both design verification and validation review, the ISO 13485 Quality Management System for both- products and processes, can help manufacturers to attain the required systems in place even before pursuing the CE mark for the European market. Medical Device manufacturers operating outside the European market that already have a Quality Management System based on ISO 13485 can more easily obtain the CE mark for their medical devices or IVDs, as many of the directives’ conformity assessment review requirements are already met through implementing the ISO 13485 standard. In some medical devices (manufactured via ISO 13485-compliant systems), a certificate of declaration of conformity by the manufacturer is enough to attain a CE mark.

Consulting firms are specialized in document drafting, training, supporting, review and Internal auditing for all manufacturing and related services to ensure full compliance to the EN ISO 13485:2016 standard. In addition, Consulting firms can create paper systems, electronic systems, or even web-based documentation control system which may be accessed from anywhere in the world and can be tailored to your organizational structure and requirements.

Consulting companies focus mainly on medical device and IVD companies, so they understand the unique needs and manufacturing scenarios of the industry. Most of the ISO 13485 consultants are EN ISO 13485:2016 lead auditors and approved internal auditors.

ISO 13485 consultants customize your ISO 13485 quality system to meet your organizational specific needs and make sure you are ready for ISO 13485 certification audit from a Certification Body.

The latest Medical Device software validation method (life cycle process model) developed is IEC 62304:2015 or ISO 62304. The new standard covers software development & maintenance, risk management according to ISO 14971, partitioning and safety classification of software items, and software process management. As per clause 3.12 of IEC 62304:2015, a Medical Device Software means “SOFTWARE SYSTEM that has been developed for the purpose of being incorporated into the MEDICAL DEVICE being developed or that is intended for use as a MEDICAL DEVICE in its own right”.

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Yes, the consultants will visit the client location

No, the consultants do not help with device design.

Yes, the company is ready to sign an NDA with the client.